MedWatch Form FDA 3500

reporting 3500.pdf

Guide for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drugs Without an Approved Application

MedWatch Form FDA 3500

OMB: 0910-0636

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0636 can be found here:

Document [pdf]

Download: pdf | pdf

Save As...

Export Data

Import Data

Goto Page?

Reset Form

U.S. Department of Health and Human Services

For VOLUNTARY reporting of
adverse events, product problems and
product use errors

MEDWATCH
The FDA Safety Information and
Adverse Event Reporting Program
A. PATIENT INFORMATION
1. Patient Identifier

General Instructions

4. Weight

1. Name, Strength, Manufacturer (from product label)
lb

Female

In confidence

B. ADVERSE EVENT, PRODUCT PROBLEM OR ERROR
Check all that apply:

Section D - Help

D. SUSPECT PRODUCT(S)

3. Sex
Male

FDA USE ONLY
Triage unit
sequence #

Page ____ of ____

Section A - Help

2. Age at Time of Event, or
Date of Birth:

Form Approved: OMB No. 0910-0291, Expires:10/31/08
See OMB statement on reverse.

#2
2.

Dose or Amount

Frequency

Route

Section B - Help

Adverse Event

Product Problem (e.g., defects/malfunctions)

Product Use Error

Problem with Different Manufacturer of Same Medicine

2. Outcomes Attributed to Adverse Event
(Check all that apply)
Death:

Disability or Permanent Damage
(mm/dd/yyyy)

Life-threatening

Congenital Anomaly/Birth Defect

Hospitalization - initial or prolonged

Other Serious (Important Medical Events)

Required Intervention to Prevent Permanent Impairment/Damage (Devices)
3. Date of Event (mm/dd/yyyy)

4. Date of this Report (mm/dd/yyyy)

09/14/2007

#1
#2
3. Dates of Use (If unknown, give duration) from/to (or
best estimate)
#1

5. Event Abated After Use
Stopped or Dose Reduced?
Doesn't
#1
Yes
No
Apply

Doesn't
Apply

Yes

Doesn't
Apply

7. Expiration Date

Yes

Doesn't
Apply

9. NDC # or Unique ID

6. Lot #

Section E - Help

E. SUSPECT MEDICAL DEVICE

PLEASE TYPE OR USE BLACK INK

8. Event Reappeared After
Reintroduction?

#1
#2

5. Describe Event, Problem or Product Use Error

Yes

4. Diagnosis or Reason for Use (Indication)

1. Brand Name
2. Common Device Name
3. Manufacturer Name, City and State

Lot #

4. Model #

5. Operator of Device
Health Professional

Catalog #

Expiration Date (mm/dd/yyyy)

Serial #

Other #

6. If Implanted, Give Date (mm/dd/yyyy)

Lay User/Patient
Other:

7. If Explanted, Give Date (mm/dd/yyyy)

8. Is this a Single-use Device that was Reprocessed and Reused on a Patient?
Yes

9. If Yes to Item No. 8, Enter Name and Address of Reprocessor

(Continue on page 2)
6. Relevant Tests/Laboratory Data, Including Dates

F. OTHER (CONCOMITANT) MEDICAL PRODUCTS Section F - Help
Product names and therapy dates (exclude treatment of event)

(Continue on page 2)
7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies,
race, pregnancy, smoking and alcohol use, liver/kidney problems, etc.)

(Continue on page 2)
Section G - Help
statement)
G. REPORTER (See(Confidentiality
confidentiality
section on back)
1. Name and Address

E-mail

Phone #

(Continue on page 2)

C. PRODUCT AVAILABILITY

2. Health Professional? 3. Occupation

Section C - Help

Yes

Product Available for Evaluation? (Do not send product to FDA)
Yes

Returned to Manufacturer on:
(mm/dd/yyyy)

FORM FDA 3500 (10/05)

5. If you do NOT want your identity disclosed
to the manufacturer, place an "X" in this box:

4. Also Reported to:
Manufacturer
User Facility
Distributor/Importer

Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event.

Save As...

Goto Page?

Reset Form

ADVICE ABOUT VOLUNTARY REPORTING
Detailed instructions available at: http://www.fda.gov/medwatch/report/consumer/instruct.htm
Report adverse events, product problems or product
use errors with:

..
..
.
.

Medications (drugs or biologics)
Medical devices (including in-vitro diagnostics)
Combination products (medication & medical devices)
Human cells, tissues, and cellular and tissue-based
products
Special nutritional products (dietary supplements,
medical foods, infant formulas)
Cosmetics

-Fold Here-

Suspected counterfeit product
Suspected contamination
Questionable stability
Defective components
Poor packaging or labeling
Therapeutic failures (product didn't work)

Report SERIOUS adverse events. An event is serious
when the patient outcome is:

..
..
..
.

How to report:
Just fill in the sections that apply to your report
Use section D for all products except medical devices
Attach additional pages if needed
Use a separate form for each patient
Report either to FDA or the manufacturer (or both)
Other methods of reporting:

Report product problems - quality, performance or safety
concerns such as:

..
..
..

..
..
..
.

Report even if:
You're not certain the product caused the event
You don't have all the details

Death
Life-threatening
Hospitalization - initial or prolonged
Disability or permanent damage
Congenital anomaly/birth defect
Required intervention to prevent permanent
impairment or damage
Other serious (important medical events)

..
.

1-800-FDA-0178 -- To FAX report
1-800-FDA-1088 -- To report by phone
www.fda.gov/medwatch/report.htm -- To report online

If your report involves a serious adverse event with a
device and it occurred in a facility outside a doctor's office,
that facility may be legally required to report to FDA and/or
the manufacturer. Please notify the person in that facility
who would handle such reporting.

-Fold Here-

If your report involves a serious adverse event with a
vaccine call 1-800-822-7967 to report.
Confidentiality: The patient's identity is held in strict
confidence by FDA and protected to the fullest extent of
the law. FDA will not disclose the reporter's identity in
response to a request from the public, pursuant to the
Freedom of Information Act. The reporter's identity,
including the identity of a self-reporter, may be shared with
the manufacturer unless requested otherwise.

The public reporting burden for this collection of information has been estimated to average 36 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection
of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for
reducing this burden to:
Department of Health and Human Services
Food and Drug Administration - MedWatch
10903 New Hampshire Avenue
Building 22, Mail Stop 4447
Silver Spring, MD 20993-0002

Please DO NOT
RETURN this form
to this address.

OMB statement:
"An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of
information unless it displays a currently valid
OMB control number."

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

FORM FDA 3500 (10/05) (Back)

Please Use Address Provided Below -- Fold in Thirds, Tape and Mail

DEPARTMENT OF
HEALTH & HUMAN SERVICES

NO POSTAGE
NECESSARY
IF MAILED
IN THE
UNITED STATES
OR APO/FPO

Public Health Service
Food and Drug Administration
Rockville, MD 20857
Official Business
Penalty for Private Use $300

BUSINESS REPLY MAIL
FIRST CLASS MAIL

PERMIT NO. 946

ROCKVILLE MD

MEDWATCH
The FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787

Save As...

Goto Page?

Reset Form
(CONTINUATION PAGE)

U.S. Department of Health and Human Services

MEDWATCH

For VOLUNTARY reporting of
adverse events and product problems

The FDA Safety Information and
Adverse Event Reporting Program

Page ____ of ____

Back to Form

Section B: 5. Describe Problem or Product Use Error (continued)

Back to Form

Section B: 6. Relevant Tests/Laboratory Data, Including Dates (continued)

Back to Form

Section B: 7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, race, pregnancy, smoking and alcohol use, liver/kidney problems dysfunction, etc.) (continued)

Back to Form

Section F: OTHER (CONCOMITANT) MEDICAL PRODUCTS - Product Names and Therapy Dates (Exclude treatment of event) (continued)

Save As...

Back to Form

Goto Page?

Reset Form

General Instructions for Completing the MedWatch Form FDA 3500

For use by health professionals and consumers for VOLUNTARY reporting of adverse events, product use errors and
product quality problems with:
•

drugs

•

biologics, (including blood components, blood derivatives, allergenics, human cells, tissues, and cellular and
tissue-based products (HCT/Ps),

•

medical devices (including in vitro diagnostics),

•

combination products [e.g. drug-device, biologic-device]

•

special nutritional products (dietary supplements, infant formulas, medical foods)

•

cosmetics

Adverse events involving vaccines should be reported to the Vaccine Adverse Event Reporting System (VAERS),
http://vaers.hhs.gov/pdf/vaers_form.pdf Adverse events involving investigational (study) drugs, such as those
relating to Investigational New Drug (IND) applications should be reported as required in the study protocol and
sent to the address and contact person listed in the study protocol. They should generally not be submitted to FDA
MedWatch as voluntary reports.
Note for consumers: If possible, please take the 3500 form to your health professional (e.g., doctor or
pharmacist) so that information based on your medical record that can help in the evaluation of your report
will be provided. If, for whatever reason, you do not wish to have your health professional fill out the form, you
are welcome to do so yourself.

GENERAL INSTRUCTIONS
•

Please make sure that all entries are either typed,
printed in a font no smaller than 8 point, or written
using black ink.

•

Please complete all sections that apply to your
report.

•

Dates should be entered as mm/dd/yyyy (e.g., June
3, 2005 = 06/03/2005). If exact dates are unknown,
please provide the best estimate (see B3).

•

For narrative entries, if the fields do not provide
adequate space, attach additional pages as needed.

•

If attaching additional
lowing:

pages, please do the fol-

• Include the phrase continued at the end of each
field that has additional information continued
onto another page
•

Section D, Suspect product[s], should be used to
report on special nutritional products and cosmetics
as well as drugs or biologics, including human cells,
tissues, and cellular and tissue-based products
(HCT/Ps).

•

If your report involves a serious adverse event with a
device and it occurred in a facility other than a
doctor’s office, that facility may be legally required to
report to FDA and/or the manufacturer. Please notify
the person in that facility who would handle such
reporting.

• Identify all attached pages as Page __ of __
• Indicate the appropriate section and block number
next to the narrative continuation

QUESTIONS ABOUT VOLUNTARY REPORTING?
Call MedWatch at 800-FDA-1088 or 301-796-1935

Save As...

Go Back to Form

Goto Page?

Reset Form

SECTION A: PATIENT INFORMATION

Complete a separate form for each patient, unless the
report involves a medical device where multiple patients
were adversely affected through the use of the same
device. In that case, please indicate the number of
patients in block B5 (Describe event or problem) and
complete Section A and blocks B2, B5, B6, B7, and F for
each patient. Enter the corresponding patient identifier in
block A1 for each patient involved in the event.
Parent-child/fetus report(s) are those cases in which
either a fetus/breast-feeding infant or the mother, or both,
have an adverse event that is possibly associated with a
product administered to the mother during pregnancy.
Several general principles are used for filing these
reports:
• If there has been no event affecting the child/fetus,
report only on the parent.
• For those cases describing fetal death, miscarriage
or abortion, report the parent as the patient in the
report.
• When only the child/fetus has an adverse
reaction/event (other than fetal death, miscarriage
or abortion), the information provided in section A
applies to the child/fetus. However, the information
in section D would apply to the parent who was the
source of exposure to the product.
• When a newborn baby is found to have a birth
defect/congenital anomaly that the initial reporter
considers possibly associated with a product
administered to the mother during pregnancy, the
patient is the newborn baby.
• If both the parent and the child/fetus have adverse
events, separate reports should be submitted for
each patient.
A1:

the case if you are contacted for more information. Do
not use the patient’s name or social security number.
The patient’s identity is held in strict confidence by FDA
and protected to the fullest extent of the law. The FDA
will not disclose the reporter’s identity in response to a
request from the public, pursuant to the Freedom of
Information Act.
If no patient was involved (such as may be the case with
a product problem), enter none.
A2:

Age at Time of Event or Date of Birth

Provide the most precise information available. Enter the
patient’s birth date, if known, or the patient’s age at the
time of event onset. For age, indicate time units
used (e.g., years, months, days).
• If the patient is 3 years or older, use years (e.g., 4
years)
• If the patient is less than 3 years old, use months
(e.g., 24 months)
• If the patient is less than 1 month old, use days
(e.g., 5 days)
• Provide the best estimate if exact age is unknown
A3:

Sex

Enter the patient’s gender. If the adverse event is a
congenital anomaly/birth defect, report the sex of the
child.
A4:

Weight

Patient Identifier

Please provide the patient’s initials or some other type of
identifier that will allow you, the reporter, to readily locate

Indicate whether the weight is in pounds (lb) or
kilograms (kg). Make a best estimate if exact weight is
unknown.

Save As...

Go Back to Form

Goto Page?

Reset Form

SECTION B: ADVERSE EVENT, PRODUCT PROBLEM, PRODUCT USE ERROR

B1: Adverse Event, Product Problem, Product Use
Error, or Problem with Different Manufacturer of
Same Medicine
Choose the appropriate box(es). If a product problem
may have caused or contributed to the adverse event,
check the both boxes.
Adverse event: Any incident where the use of a
medication (drug or biologic, including HCT/P), at any
dose, a medical device (including in vitro diagnostics) or
a special nutritional product (e.g., dietary supplement,
infant formula or medical food) is suspected to have
resulted in an adverse outcome in a patient.
To report, it is not necessary to be certain of a cause/
effect relationship between the adverse event and the
use of the medical product(s) in question. Suspicion of
an association is sufficient reason to report. Submission
of a report does not constitute an admission that medical
personnel or the product caused or contributed to the
event.
Please limit your submissions to those events that are
serious. An event is classified as serious when the
patient outcome is:
•
•
•
•
•
•

Death
Life-threatening
Hospitalization (initial or prolonged)
Disability or Permanent Damage
Congenital anomaly/Birth Defect
Required medical or surgical intervention to
prevent permanent impairment or damage
(Devices)
• Other Serious (Important Medical Events)
Please see instructions for block B2 for further information on each of these criteria.
Product problem (e.g., defects/malfunctions): Any
report regarding the quality, performance, or safety of
any medication, medical device or special nutritional
product. In addition, please select this category when
reporting device malfunctions that could lead to a death
or serious injury if the malfunction were to recur. Product
problems include, but are not limited to, such concerns
as:
•
•
•
•
•
•

Suspected counterfeit product
Suspected contamination
Questionable stability
Defective components
Therapeutic failures (product didn’t work)
Product confusion (caused by name, labeling,
design or packaging)
• Suspected superpotent or subpotent medication
• Labeling problems caused by printing errors/
omissions

Product Use Error:
Medication Use Error: Any report of a medication error
regardless of patient involvement or outcome. Also
report circumstances or events that have the capacity to
cause error (e.g., similar product appearance, similar
packaging and labeling, sound-alike/ look-alike names,
etc.).
Medication errors can and do originate in all stages of
the medication use system, which includes selecting and
procuring drugs, prescribing, preparing and dispensing,
administering and monitoring. A medication error is
defined as “any preventable event that may cause or
lead to inappropriate medication use or patient harm
while the medication is in the control of the health care
professional, patient, or consumer. Such events may be
related to professional practice, health care products,
procedures, and systems, including prescribing, order
communication, product labeling, packaging, nomenclature, compounding, dispensing, distribution, administration, education, monitoring and use.”
Medical Device Use Error: Health care professionals,
patients, and consumers can unintentionally cause harm
to patients or to themselves when using medical
devices. These problems can often arise due to
problems with the design of the medical device or the
manner in which the device is used. Often use-errors are
caught and prevented before they can do harm (close
call). Report use errors regardless of patient involvement
or outcome. Also report circumstances or events that
could cause use errors. Medical device use errors
usually occur for one or more of the following reasons:
• Users expect devices to operate differently than
they do.
• Product use is inconsistent with use’s expectations or intuition,
• Product use requires physical, perceptual, or cognitive abilities that exceed those of the user,
• Devices are used in ways not anticipated by the
manufacturer,
• Product labeling or packaging is confusing or inadequate,
• The environment adversely effects or influences
device use
Problem with Different Manufacturer of Same Medicine:

Any incident, to include, but not limited to, differences in
noted therapeutic response, suspected to have resulted
from a switch, or change, from one manufacturer to
another manufacturer of the same medicine or drug
product. This could be changes from a brand name drug
product to a generic manufacturer’s same product, or
from a generic manufacturer’s product to the same

(continued on next page)

Save As...

Goto Page?

Reset Form

SECTION B: ADVERSE EVENT, PRODUCT PROBLEM, PRODUCT USE ERROR (continued)

Go Back to Form

product as supplied by a different generic manufacturer,
or from a generic manufacturer’s product to a brand
name manufacturer of the same product. In order to
fully evaluate the incident, please include in Section B5,
if available, specific information relative to the switch
between different manufacturers of the same medicine,
to include, but not limited to, the names of the
manufacturers, length of treatment on each manufacture’s product, product strength, and any relevant
clinical data.
B2: Outcomes Attributed to Adverse Event: Indicate
all that apply to the reported event:
Death: Check only if you suspect that the death was an
outcome of the adverse event, and include the date if
known.
Do not check if:
• The patient died while using a medical product,
but there was no suspected association between
the death and the use of the product
• A fetus is aborted because of a congenital
anomaly (birth defect), or is miscarried

Congenital Anomaly/Birth Defect: Check if you
suspect that exposure to a medical product prior to
conception or during pregnancy may have resulted in an
adverse outcome in the child.
Required Intervention to Prevent Permanent
Impairment or Damage (Devices): Check if you believe
that medical or surgical intervention was necessary to
preclude permanent impairment of a body function, or
prevent permanent damage to a body structure, either
situation suspected to be due to the use of a medical
product.
Other Serious (Important Medical Events): Check
when the event does not fit the other outcomes, but the
event may jeopardize the patient and may require
medical or surgical intervention (treatment) to prevent
one of the other outcomes. Examples include allergic
brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood
dyscrasias (blood disorders) or seizures/convulsions that
do not result in hospitalization. The development of drug
dependence or drug abuse would also be examples of
important medical events.
B3:

Date of Event

Life-threatening: Check if suspected that:
• The patient was at substantial risk of dying at the
time of the adverse event, or
• Use or continued use of the device or other
medical product might have resulted in the death
of the patient
Hospitalization (initial or prolonged): Check if admission to the hospital or prolongation of hospitalization
was a result of the adverse event.
Do not check if:
• A patient in the hospital received a medical product and subsequently developed an otherwise
nonserious adverse event, unless the adverse
event prolonged the hospital stay

Provide the actual or best estimate of the date of first
onset of the adverse event. If day is unknown, month
and year are acceptable. If day and month are unknown,
year is acceptable.
• When a newborn baby is found to have a
congenital anomaly, the event onset date is the
date of birth of the child
• When a fetus is aborted because of a congenital
anomaly, or is miscarried, the event onset date is
the date pregnancy is terminated
• If information is available as to time during
pregnancy when exposure occurred, indicate that
information in narrative block B5.
B4:

Date of this Report

The date the report is filled out.
Do check if:
B5:
• A patient is admitted to the hospital for one or
more days, even if released on the same day
• An emergency room visit results in admission to
the hospital Emergency room visits that do not
result in admission to the hospital should be
evaluated for one of the other serious outcomes
(e.g., life-threatening; required intervention to prevent permanent impairment or damage; other
serious (medically important event)
Disability or Permanent Damage: Check if the adverse
event resulted in a substantial disruption of a person’s
ability to conduct normal life functions. Such would be
the case if the adverse event resulted in a significant,
persistent or permanent change, impairment, damage or
disruption in the patient’s body function/structure, physical activities and/or quality of life.

Describe Event, Problem or Product Use Error

For an adverse event:
Describe the event in detail, including a description of
what happened and a summary of all relevant clinical
information (medical status prior to the event; signs
and/or symptoms; differential diagnosis for the event in
question; clinical course; treatment; outcome, etc.). If
available and if relevant, include synopses of any office
visit notes or the hospital discharge summary. To save
time and space (and if permitted by your institution),
please attach copies of these records with any
confidential information deleted. Do not identify any
patient, physician, or institution by name. The reporter’s
identity should be provided in full in Section G.

(continued on next page)

Save As...

Goto Page?

Reset Form

SECTION B: ADVERSE EVENT, PRODUCT PROBLEM, PRODUCT USE ERROR (continued)

Go Back to Form

Information as to any environmental conditions that may
have influenced the event should be included, particularly when (but not exclusive to) reporting about a
device.
• Results of relevant tests and laboratory data
should be entered in block B6. (See instructions
for B6).
• Preexisting medical conditions and other relevant
history belong in block B7. Be as complete as
possible, including time courses for preexisting
diagnoses (see instructions for B7).
If it is determined that reuse of a medical device labeled
for single use may have caused or contributed to an
adverse patient outcome, please report in block B5 the
facts of the incident and the perceived contribution of
reuse to the occurrence.
For a product problem: Describe the problem (quality,
performance, or safety concern) in sufficient detail so
that the circumstances surrounding the defect or malfunction of the medical product can be understood.
• If available, the results of any evaluation of a
malfunctioning device and, if known, any relevant
maintenance/service information should be included in this section
• For a medication or special nutritional product
problem, please indicate if you have retained a
sample that would be available to FDA
For a product use error: Describe the sequence of
events leading up to the error in sufficient detail so that
the circumstances surrounding the error can be
understood.
•

•

For Medication Use Errors: Include a description of
the error, type of staff involved, work environment in
which the error occurred, indicate causes or
contributing factors to the error, location of the error,
names of the products involved (including the trade
(proprietary) and established (proper) name,
manufacturer, dosage form, strength, concentration,
and type and size of container.
For Medical Device Use Errors: Report
circumstances or events that could cause use errors.
Medical device use errors usually occur for one or
more of the following reasons:
• Users expect devices to operate differently than
they do.
• Product use is inconsistent with user’s expectations or intuition,
• Product use requires physical, perceptual, or cognitive abilities that exceed those of the user,
• Devices are used in ways not anticipated by the
manufacturer,
• Product labeling or packaging is confusing or
inadequate,
• The environment adversely effects or influences
device use

For a problem with a different manufacturer of the
same medicine:
Please include specific information relative to the switch
between different manufacturers of the same medicine,
to include, but not limited to, the names of the
manufacturers, length of treatment on each manufacturer’s product, product strength, and any relevant
clinical data.
B6:

Relevant Tests/Laboratory Data, Including Dates

Please provide all appropriate information, including
relevant negative test and laboratory findings, in order to
most completely convey how the medical work-up/
assessment led to strong consideration of medical
product-induced disease as etiology for clinical status, as
other differential diagnostic considerations were being
eliminated.
Please include:
• Any relevant baseline laboratory data prior to the
administration or use of the medical product
• All laboratory data used in diagnosing the event
• Any available laboratory data/engineering analyses (for devices) that provide further information
on the course of the event
If available, please include:
• Any pre- and post-event medication levels and
dates (if applicable)
• Synopses of any relevant autopsy, pathology,
engineering, or lab reports
If preferred, copies of any reports may be submitted as
attachments, with all confidential information deleted. Do
not identify any patient, physician or institution by
name. The initial’s reporter’s identity should be provided
in full in Section G.
B7: Other Relevant History, Including Preexisting
Medical Conditions
Knowledge of other risk factors can help in the
evaluation of a reported adverse event. If available,
provide information on:
• Other known conditions in the patient, e.g.,
• Hypertension (high blood pressure)
• Diabetes mellitus
• liver or kidney problems
• Significant history
• Race
• Allergies
• Pregnancy history
• Smoking and alcohol use, drug abuse
• Setting

Save As...

Go Back to Form

Goto Page?

Reset Form

SECTION C: PRODUCT AVAILABILITY

Product available for evaluation? (Do not send the product to FDA.)
To evaluate a reported problem with a medical product, it is often critical to be able to examine the product. Please
indicate whether the product is available for evaluation. Also indicate if the product was returned to the manufacturer
and, if so, the date of the return.

SECTION D: SUSPECT PRODUCT(S)
For adverse event reporting:
A suspect product is one that you suspect is associated
with the adverse event. In Section F enter other
concomitant medical products (drugs, biologics including
Human cells, tissues, and cellular and tissue-based
products (HCT/Ps,) medical devices, etc.) that the patient
was using at the time of the event but which you do not
think were involved in the event.
Up to two (2) suspect products may be reported on one
form (#1=first suspect product, #2=second suspect
product). Attach an additional form if there were more
than two suspect products associated with the reported
adverse event.
For product quality problem reporting:
A suspect product is the product that is the subject of the
report. A separate form should be submitted for each
individual product problem report.
Identification of the labeler/distributor and pharmaceutical
manufacturer and labeled strength of the product is important for prescription or non-prescription products.
This section may also be used to report on special
nutritional products (e.g., dietary supplements, infant
formula or medical foods), cosmetics, human cells,
tissues, or cellular and tissue-based products (HCT/Ps)
or other products regulated by FDA.
If reporting on a special nutritional or a drug product
quality problem, please attach labeling/packaging if
available.

For human cells, tissues, and cellular and tissue-based
products (HCT/Ps), please provide the common name of
the HCT/P. You can also indicate if the HCT/P has a
proprietary or trade name. Examples: Achilles tendon,
Iliac crest bone or Islet cells.
D2:

Dose or Amount, Frequency, Route

Describe how the product was used by the patient (e.g.,
500 mg QID orally or 10 mg every other day IV). For
reports involving overdoses, the amount of product used
in the overdose should be listed, not the prescribed
amount. (See APPENDIX for list of Routes of
Administration on the next page)
D3:

Dates of Use

Provide the date administration was started (or best
estimate) and the date stopped (or best estimate). If no
dates are known, an estimated duration is acceptable
(e.g., 2 years) or if therapy was less than one day, then
duration is appropriate (e.g., 1 dose or 1 hour for an IV).
For human cells, tissues, and cellular and tissue-based
products, provide the date of transplant and if applicable,
the date of explanation.
D4:

Diagnosis or Reason for Use (Indication)

Provide the reason or indication for which the product
was prescribed or used in this particular patient.
D5: Event Abated After Use Stopped or Dose
Reduced

If reporting on a special nutritional only, please provide
directions for use as listed on the product labeling.

If available, this information is particularly useful in the
evaluation of a suspected adverse event. In addition to
checking the appropriate box, please provide supporting
lab tests and dates, if available, in block B6.

D1:

D6:

Name, Strength, Manufacturer

Use the trade/brand name. If the trade/brand name is not
known or if there is no trade/brand name, use the generic
product name and the name of the manufacturer or
labeler. These names are usually found on the product
packaging or labeling. Strength is the amount in each
tablet or capsule, the concentration of an injectable, etc.
(such as “10mg”, “100 units/cc”, etc.).

Lot #

If known, include the lot number(s) with all product quality
problem reports, or any adverse event report with a
biologic, or medication.
D7:

Expiration Date

Please include if available.

(continued on next page)

Save As...

Go Back to Form

D8:

Goto Page?

Reset Form

SECTION D: SUSPECT PRODUCTS(S) (continued)

Event Reappeared After Reintroduction

This information is particularly useful in the evaluation of a
suspected adverse event. In addition to checking the
appropriate box, please provide a description of what
happened when the drug was stopped and then restarted in
block B5, and any supporting lab tests and dates in block
B6.

D9:

NDC # or Unique ID

The national drug code (NDC #) is requested only when
reporting a drug product problem. Zeros and dashes should
be included as they appear on the label. NDC # can be
found on the original product label and/or packaging, but is
usually not found on dispensed pharmacy prescriptions.
If the product has a unique or distinct identification code,
please provide this here. This is applicable to human cells,
tissues, and cellular and tissue- based products (HCT/Ps).

APPENDIX - ROUTES OF ADMINISTRATION
Auricular (otic) 001
Buccal 002
Cutaneous 003
Dental 004
Endocervical 005
Endosinusial 006
Endotracheal 007
Epidural 008
Extra-amniotic 009
Hemodialysis 010
Intra corpus cavernosum 011
Intra-amniotic 012
Intra-arterial 013
Intra-articular 014
Intra-uterine 015
Intracardiac 016
Intracavernous 017

Intracerebral 018
Intracervical 019
Intracisternal 020
Intracorneal 021
Intracoronary 022
Intradermal 023
Intradiscal (intraspinal) 024
Intrahepatic 025
Intralesional 026
Intralymphatic 027
Intramedullar (bone marrow) 028
Intrameningeal 029
Intramuscular 030
Intraocular 031
Intrapericardial 032
Intraperitoneal 033
Intrapleural 034

Intrasynovial 035
Intratumor 036
Intrathecal 037
Intrathoracic 038
Intratracheal 039
Intravenous bolus 040
Intravenous drip 041
Intravenous (not otherwise specified) 042
Intravesical 043
Iontophoresis 044
Occlusive dressing technique 045
Ophthalmic 046
Oral 047
Oropharingeal 048
Other 049
Parenteral 050
Periarticular 051

Perineural 052
Rectal 053
Respiratory (inhalation) 054
Retrobulbar 055
Sunconjunctival 056
Subcutaneous 057
Subdermal 058
Sublingual 059
Topical 060
Transdermal 061
Transmammary 062
Transplacental 063
Unknown 064
Urethral 065
Vaginal 066

Save As...

Go Back to Form

Goto Page?

Reset Form

SECTION E: SUSPECT MEDICAL DEVICE

The suspect medical device is 1) the device that may
have caused or contributed to the adverse event or 2)
the device that malfunctioned.
In Section F, report other concomitant medical products
(drugs, biologics including HCT/Ps, medical devices,
etc.) that the patient was using at the time of the event
but which you do not think were involved in the event.
If more than one suspect medical device was involved in
the event, complete all of Section E for the first device
and attach a separate completed Section E for each
additional device.
If the suspect medical device is a single use device that
has been reprocessed, then the reprocessor is now the
device manufacturer.
E1:

Common Device Name

The generic or common name of the suspect medical
device or a generally descriptive name (e.g., urological
catheter, heart pacemaker, patient restraint, etc.).
Please do not use broad generic terms such as
"catheter", "valve", "screw", etc.
E3:

This number can be found on the device label or
accompanying packaging; it is assigned by the
manufacturer, and should be specific to each device.
Lot#:
This number can be found on the label or packaging
material.
Expiration date (mm/dd/yyyy):
If available, this date can often be found on the device
itself or printed on the accompanying packaging.
Other #:

Brand Name

The trade or proprietary name of the suspect medical
device as used in product labeling or in the catalog (e.g.,
Flo-Easy Catheter, Reliable Heart Pacemaker, etc.).
This information may 1) be on a label attached to a
durable device, 2) be on a package of a disposable
device, or 3) appear in labeling materials of an
implantable device. Reprocessed single use devices
may bear the Original Equipment Manufacturer (OEM)
brand name. If the suspect device is a reprocessed
single use device enter "NA".
E2:

Serial #:

Manufacturer Name, City and State

If available, list the full name, city and state of the
manufacturer of the suspected medical device. If the
answer is Block E8 is "yes", then enter the name, city
and state of the reprocessor.
E4: Model #, Catalog #, Serial #, Lot #, Expiration
date, Other #
If available, provide any or all identification numbers
associated with the suspect medical device exactly as
they appear on the device or device labeling. This
includes spaces, hyphens, etc.

Any other applicable identification number (e.g., component number, product number, part bar-coded product
ID, etc.)
E5:

Operator of Device

Indicate the type (not the name) of person operating or
using the suspect medical device on the patient at the
time of the event as follows:
• Health professional = physician, nurse, respiratory
therapist, etc.
• Lay user/patient = person being treated, parent/
spouse/friend of the patient
• Other = nurses aide, orderly, etc.
E6:

If implanted, give date (mm/dd/yyyy)

For medical devices that are implanted in the patient,
provide the implant date or your best estimate. If day is
unknown, month and year are acceptable. If month and
day are unknown, year is acceptable.
E7:

If explanted, give date (mm/dd/yyyy)

If an implanted device was removed from the patient,
provide the explantation date or your best estimate. If
day is unknown, month and year are acceptable. If
month and day are unknown, year is acceptable.
E8: Is this a Single-use Device that was return
before Reprocessed and Reused on a Patient?

Model #:

Indicate "Yes" or "No".

The exact model number found on the device label or
accompanying packaging.

E9: If Yes to Item No.8, Enter Name and Address of
Reprocessor:

Catalog #:

Enter the name and address of the reprocessor of the
single-use device. Anyone who reprocesses single-use
devices for reuse in humans is the manufacturer of the
reprocessed device.

The exact number as it appears in the manufacturer’s
catalog, device labeling, or accompanying packaging.

Save As...

Go Back to Form

Goto Page?

Reset Form

SECTION F: OTHER (CONCOMITANT) MEDICAL PRODUCTS

Product names and therapy dates (exclude treatment of event)
Information on the use of concomitant medical products can frequently provide insight into previously unknown
interactions between products, or provide an alternative explanation for the observed adverse event. Please list and
provide product names and therapy dates for any other medical products (drugs, biologics including HCT/Ps, medical
devices, etc.) that the patient was using at the time of the event. Do not include products used to treat the event.

SECTION G: REPORTER
FDA recognizes that confidentiality is an important concern in the context of adverse event reporting. The
patient’s identity is held in strict confidence by FDA and protected to the fullest extent of the law. However, to
allow for timely follow-up in serious cases, the reporter’s identity may be shared with the manufacturer unless
specifically requested otherwise in block G5. The FDA will not disclose the reporter’s identity in response to a
request from the public, pursuant to the Freedom of Information Act.
G1:

Name, Address, Phone #, Email

Please provide the name, mailing address, phone number
and E-mail address of the person who can be contacted
to provide information on the event if follow-up is
necessary. While optional, providing the fax number
would be most helpful, if available. This person will also
receive an acknowledgment letter from FDA on receipt of
the report.
G2:

Health Professional?

Please indicate whether you are a health professional
(e.g. physician, pharmacist, nurse, etc.) or not.
G3:

Occupation:

Please indicate your occupation (particularly type of
health professional), and include specialty, if appropriate.

G4:

Also Reported to:

Please indicate whether you have also notified or
submitted a copy of this report to the manufacturer
and/or distributor of the product, or, in the case of
medical device reports only, to the user facility
(institution) in which the event occurred. This information
helps to track duplicate reports in the FDA database.
G5: Release
manufacturer

reporter’s

identify

the

In the case of a serious adverse event, FDA may provide
name, address and phone number of the reporter
denoted in block G1 to the manufacturer of the suspect
product. If you do not want your identity released to the
manufacturer, please put an X in this box.

File Type	application/pdf
File Title	Adobe:FDA-3500_8-02-05.IFD
Author	bdoyle
File Modified	2007-09-14
File Created	2005-11-07