Form FDA 3500 FDA 3500 MedWatch for VOLUNTARY reporting of adverse events, prod

Form Approved: OMB No. 0910-0291, Expires: 12/31/2011
See OMB statement on reverse.

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

Page 1 of

A. PATIENT INFORMATION

2.

1. Patient Identifier 2. Age at Time of Event or
Date of Birth:

FDA USE ONLY
Triage unit
sequence #

Frequency

Dose or Amount

Route

#1

4. Weight

3. Sex

lb

Female

#2
or

Male

In confidence

kg

B. ADVERSE EVENT, PRODUCT PROBLEM OR ERROR
Check all that apply:
1.

Adverse Event

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

Product Use Error

Problem with Different Manufacturer of Same Medicine

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

Doesn't
Apply
8. Event Reappeared After
Reintroduction?
Doesn't
#1
Yes
No
Apply

4. Diagnosis or Reason for Use (Indication)
#1

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)

#2

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

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

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

6. Lot #
#1

7. Expiration Date
#1

#2

#2

#2

Yes

No

#2

Yes

No

Doesn't
Apply

9. NDC # or Unique ID

E. SUSPECT MEDICAL DEVICE
1. Brand Name

5. Describe Event, Problem or Product Use Error

PLEASE TYPE OR USE BLACK INK

2a. Common Device Name

2b. Procode

3. Manufacturer Name, City and State

Lot #

4. Model #

5. Operator of Device
Health Professional

Catalog #

Expiration Date (mm/dd/yyyy)

Serial #

Unique Identifier (UDI) #

Lay User/Patient
Other:

6. Relevant Tests/Laboratory Data, Including Dates

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

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

8. Is this a Single-use Device that was Reprocessed and Reused on a Patient?
Yes
No
9. If Yes to Item No. 8, Enter Name and Address of Reprocessor

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

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

G. REPORTER (See confidentiality section on back)
1. Name and Address

C. PRODUCT AVAILABILITY

Name:

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

Address:

Yes

No

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

D. SUSPECT PRODUCT(S)
1. Name, Strength, Manufacturer (from product label)
#1 Name:
Strength:
Manufacturer:
#2 Name:
Strength:
Manufacturer:

FORM FDA 3500 (3/12)

State:

Phone #

2. Health Professional? 3. Occupation
Yes

ZIP:

E-mail

No

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.