U.S. Department of Health and Human Services

Food and Drug Administration

MEDWATCH

FORM FDA 3500 (2/19)
The FDA Safety Information and
Adverse Event Reporting Program

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

Form Approved: OMB No. 0910-0291, Expires: 11-30-2021

See PRA statement on reverse.

FDA Use only

Triage unit sequence#
FDA Rec. Date

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-2018

A. PATIENT INFORMATION

B. ADVERSE EVENT, PRODUCT PROBLEM

C. PRODUCT AVAILABILITY

D. SUSPECT PRODUCTS

#1
#2
Dose or Amount Frequency Route
#1 Start
#1 Stop
Is therapy still on-going?
#2 Start
#2 Stop
Is therapy still on-going?
#1
#2
#1
#2
#1
#2

E. SUSPECT MEDICAL DEVICE

F. OTHER (CONCOMITANT) MEDICAL PRODUCTS

G. REPORTER (See confidentiality section on back)

Last Name:
First Name:
Address:
City:
State/Province/Region:
ZIP/Postal Code:
Last Name:
Country:
Phone #:
Email: