Form FDA 3500A FDA 3500A MedWatch (for use by user-facilities, importers, distrib

Form Approved: OMB No. 0910-0291, Expires: 6/30/2015
See PRA statement on reverse.

For use by user-facilities,
importers, distributors and manufacturers
for MANDATORY reporting

U.S. Department of Health and Human Services
Food and Drug Administration

MEDWATCH
FORM FDA 3500A (5/15)

Mfr Report #
UF/Importer Report #

Page 1 of
FDA Use Only

Note: For date prompts of “dd-mmm-yyyy” please use 2-digit day, 3-letter month
abbreviation, and 4-digit year; for example, 01-Jul-2015.

3. Dose
#1

Frequency

Route Used

A. PATIENT INFORMATION
1. Patient Identifier

2. Age

Year(s)

Month(s) 3. Sex

Week(s)

Days(s)

Female

or Date of Birth (e.g., 08 Feb 1925)
In Confidence
5.a. Ethnicity (Check
single best answer)

4. Weight

NNN.N
format

24-Mar-2015

4. Therapy Dates (If unknown, give duration) from/
to (or best estimate)) (dd-mmm-yyyy)
#1

lb

Male

kg

5.b. Race (Check all that apply)
Asian

Black or African American

Not Hispanic/Latino

Native Hawaiian or Other Pacific Islander

5. Diagnosis for Use (Indication)
#1 The entry field will allow for two lines of

White

entry text at about this size.

B. ADVERSE EVENT OR PRODUCT PROBLEM
1.

Adverse Event

and/or

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

Include date (dd-mmm-yyyy):

6. Is the Product
Compounded?

25-Apr-2015

Life-threatening

Disability or Permanent Damage

Hospitalization – initial or prolonged

Congenital Anomaly/Birth Defects

7. Is the Product Overthe-Counter?

#1

Yes

No

#1

Yes

No

#2

Yes

No

#2

Yes

No

No

Doesn’t
apply

#2

Yes

No

Doesn’t
apply

#1

Yes

No

Doesn’t
apply

#2

Yes

No

Doesn’t
apply

06- Nov- 2016

-

#2

-

1. Brand Name

5. Describe Event or Problem

Designer note: This is a “layout design” proof of this
form. Entry fields and 508-compliance features will be
added after this design is approved.

-

D. SUSPECT MEDICAL DEVICE

4. Date of this Report (dd-mmm-yyyy)

26- Jun- 2015

-

#1

Required Intervention to Prevent Permanent Impairment/Damage (Devices)

PLEASE TYPE OR USE BLACK INK

Yes

8. Expiration Date (dd-mmm-yyyy)

Other Serious (Important Medical Events)

3. Date of Event (dd-mmm-yyyy)

#1

10. Event Reappeared After
Reintroduction?

#2

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

9. Event Abated After Use
Stopped or Dose Reduced?

#2

American Indian or Alaskan Native

Hispanic/Latino

#2

F
O
O

PR

2. Common Device Name

2b. Procode

3. Manufacturer Name, City and State

4. Model #

5. Operator of Device

Lot#

(Continue on page 3)
6. Relevant Tests/Laboratory Data, Including Dates

Catalog #

-

Lay User/Patient

-

Other

Unique Identifier (UDI) #

Serial #
al on

Buttons are not function
layout design proof.

Health
Professional

Expiration Date (dd-mmm-yyyy)

6. If Implanted, Give Date (dd-mmm-yyyy)

Removed
“Specify”

This entry line now has
no visual prompt.
7. If Explanted, Give Date (dd-mmm-yyyy)

(Continue on page 3)
7. Other Relevant History, Including Preexisting Medical Conditions (e.g.,
allergies, pregnancy, smoking and alcohol use, liver/kidney problems, etc.)

8. Is this a single-use device that was
reprocessed and reused on a patient?

Yes

No

9. If Yes to Item 8, Enter Name and Address of Reprocessor

(Continue on page 3)

C. SUSPECT PRODUCT(S)

10. Device Available for Evaluation? (Do not send to FDA)
Yes

No

Returned to Manufacturer on:

-

-

1. Name, Manufacturer/Compounder, Strength
#1 – Name and Strength

#1 – NDC # or Unique ID

#1 – Manufacturer/Compounder

#1 – Lot #

#2 – Name and Strength

#2 – NDC # or Unique ID

#2 – Manufacturer/Compounder

#2 – Lot #

2. Concomitant Medical Products and Therapy Dates (Exclude treatment of event)

11. Concomitant Medical Products and Therapy Dates (Exclude treatment of event)

(Continue on page 3)

E. INITIAL REPORTER
1. Name and Address
First Name:

Last Name:
Address:

State/Province/Region:

City:
Country:

ZIP/Postal Code:

Phone #:

Submission of a report does not constitute an admission that medical
personnel, user facility, importer, distributor, manufacturer or product
caused or contributed to the event.

Email:

2. Health
Professional?

Yes

3. Occupation (Select from list)

No

4. Initial Reporter Also Sent
Report to FDA

Yes

No

Unk

FDA USE ONLY

MEDWATCH

Page 2 of

FORM FDA 3500A (5/15) (continued)
F. FOR USE BY USER FACILITY/IMPORTER (Devices Only)
1. Check One

2. UF/Importer Report Number

User Facility

H. DEVICE MANUFACTURERS ONLY
1. Type of Reportable Event

Importer

3. User Facility or Importer Name/Address

2. If Follow-up, What Type?

Death

Correction

Serious Injury

Additional Information

Malfunction

Response to FDA Request
Device Evaluation

3. Device Evaluated by Manufacturer?
Not Returned to Manufacturer
4. Contact Person

5. Phone Number

6. Date User Facility or
Importer Became Aware
of Event (dd-mmm-yyyy)

-

-

Device
Code

Device
Code

Method
12. Location Where Event Occurred

Home
Nursing Home

13. Report Sent to Manufacturer? (If
Yes, enter date (dd-mmm-yyyy))

Ambulatory
Surgical Facility

Outpatient Treatment
Facility

-

Other:

No

Results

Outpatient
Diagnostic Facility

Hospital

-

-

No

6. Event Problem and Evaluation Codes (Refer to coding manual)

Patient
Code

No

Yes

-

Patient
Code

-

5. Labeled for Single Use?
Yes

10. Event Problem Codes (Refer to coding manual)

11. Report Sent to FDA? (If Yes,
enter date (dd-mmm-yyyy))
Yes

-

Initial
Follow-up #

9. Approximate
Age of Device

-

Evaluation Summary Attached

No (Attach page to explain why not) or
provide code:

8. Date of This Report
(dd-mmm-yyyy)

7. Type of Report

-

Yes

4. Device Manufacture Date
(dd-mmm-yyyy)

Conclusions
7. If Remedial Action Initiated, Check Type

(Specify)

14. Manufacturer Name/Address

Recall

Notification

Initial Use of Device

Repair

Inspection

Reuse

Replace

Patient Monitoring

Relabeling

PROOF
10.

G. ALL MANUFACTURERS
1. Contact Office (and Manufacturing Site for Devices)

8. Usage of Device

Modification/
Adjustment

Unknown
9. If action reported to FDA under
21 USC 360i(f), list correction/
removal reporting number:

Other:

Additional Manufacturer Narrative

and / or

11.

Corrected Data

2. Phone Number

Name
3. Report Source
(Check all that apply)

Address

Foreign
Study
Literature
Email Address

Consumer
Health Professional
Yes

Compounding Outsourcing Facility 503B?
4. Date Received by
Manufacturer (dd-mmm-yyyy)

-

-

6. If IND, Give Protocol #

7. Type of Report
(Check all that apply)
5-day

30-day

7-day

Periodic

10-day

Initial

15-day

Follow-up # ____

9. Manufacturer Report Number

User Facility

5.

Company
Representative
Distributor

NDA #
ANDA #

Other:

IND #
BLA #
PMA/
510(k) #
Combination
Product

Yes

Pre-1938

Yes

OTC

Yes

8. Adverse Event Term(s)

This section applies only to requirements of the Paperwork Reduction Act of 1995.
The public reporting burden for this collection of information has been estimated to average 73
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
OMB Statement: "An agency may not
Food and Drug Administration
conduct or sponsor, and a person is not
Office of Chief Information Officer
required to respond to, a collection of
Paperwork Reduction Act (PRA) Staff
information unless it displays a currently
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valid OMB control number."
Please DO NOT RETURN this form to the above PRA Staff email address.

Delete Page
(CONTINUATION PAGE)

MEDWATCH
FORM FDA 3500A (5/15) (continued)

For use by user-facilities,
importers, distributors, and manufacturers
for MANDATORY reporting
Page 3 of

B.5. Describe Event or Problem (continued)

Back to Item B.5

Designer note: The action buttons on pages 2 and 3 temporarily dropped out of
the form when the functionally simpler "Acro" PDF file was generated for proof
purposes (to allow for combining pages 2 and 3 with the new page 1 PDF that was
designed in different software). Those buttons will continue to exist and work in the
final "Adobe LIveCycle" functional and 508-compliant PDF form that will be made
after FDA approves this revised layout. (In this particular form file you may see residual
text from some of the action buttons.)

Back to Item B.6

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

PROOF

Back to Item D.11 Back to Item C.10

Back to Item B.7

B.7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.) (continued)

Concomitant Medical Products and Therapy Dates (Exclude treatment of event) (For continuation of C.10 and/or D.11; please distinguish)

Other Remarks