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DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0291, Expires: 06-30-2025
See PRA statement on page 6.
Food and Drug Administration
FDA USE ONLY
Triage unit
sequence #
The FDA Safety Information and FDA Rec. Date
Adverse Event Reporting Program For VOLUNTARY reporting of adverse events, prod-
Form FDA 3500 uct problems and product use/medication errors
Note: For date prompts of “dd-mmm-yyyy” please use 2-digit day, 3-letter month abbreviation, and 4-digit year; for example, 01-Jan-1900.
A. PATIENT INFORMATION
1. Patient Identifier (In confidence) 2. Age or Date of Birth (e.g., 01-Jan-1900)
Year(s) Week(s)
Month(s) Day(s)
3a. Sex: Enter the patient’s sex at birth 3b. Gender: Enter the patient’s current gender (how the patient thinks of themself).
(the sex that a person has or was Cisgender man/boy Transgender woman/trans woman/
assigned to at birth). (gender corresponds with birth sex) male-to-female (MTF)
Male Undifferentiated Cisgender woman/girl Other gender category; please specify:
(gender corresponds with birth sex)
Female Decline to answer
Transgender man/trans man/
Decline to answer
female-to-male (FTM)
4. Weight 5. Ethnicity (Check one) 6. Race (check all that apply)
lb Hispanic/Latino American Indian/Alaska Native Native Hawaiian/
Asian Other Pacific Islander
kg Not Hispanic/Latino
Black or African American White
B. ADVERSE EVENT, PRODUCT PROBLEM
1. Type of Report (check all that apply) 2. Outcome Attributed to Adverse Event (check all that apply)
Adverse Event Death – Date of death (e.g., 01-Jan-1900):
Product Use/Medication Error Life-threatening Required Intervention to Prevent
Product Problem (e.g., defects/malfunctions) Hospitalization (initial or prolonged) Permanent Impairment/Damage
Problem with Different Manufacturer of Same Medicine Other Serious or Important Disability or Permanent Damage
Medical Events Congenital Anomaly/Birth Defects
3. Date of Event (e.g., 01-Jan-1900) 4. Date of this Report (e.g., 01-Jan-1900)
5. Describe Event, Problem or Product Use/Medication Error Characters Remaining (max. 4,000):
(field continues on next page)
Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event.
* Please see instructions
Form FDA-3500 (11/22) Page 1 of 6 PSC Publishing Services (301) 443-6740 EF
6. Relevant Test/Laboratory Data Date (e.g., 01-Jan-1900) Relevant Test/Laboratory Data Date (e.g., 01-Jan-1900)
Additional comments Characters Remaining (max. 2,000):
7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, pregnancy, tobacco product use, liver/kidney
problems, etc.) Characters Remaining (max. 2,000):
Form FDA-3500 (11/22) Page 2 of 6 (continued on next page)
C. PRODUCT AVAILABILITY
1. Product Available for Evaluation? (Do not send product to FDA) 2. Do you have a picture of the product?
Yes No Returned to Manufacturer on (e.g., 01-Jan-1900) (Check if you are including a picture) Yes
D. SUSPECT PRODUCTS
SUSPECT PRODUCT #1
This report involves: Cosmetic Dietary supplement Food/medical food Other
1. Name, Strength, Manufacturer/Compounder (from product label).
Product Name Strength Unit
NDC # or Unique ID Manufacturer/ Compounder Name Lot #
2. Dose or Amount Frequency Route
Unit Other Frequency Other Route
3. Treament Dates/Therapy Dates (give best estimate of length of treatment (start/stop) or date of dose reduction.)
Therapy started on Therapy stopped on Dose reduced on OR Duration Unit
(e.g., 01-Jan-1900) (e.g., 01-Jan-1900) (e.g., 01-Jan-1900)
Is therapy still on-going? Yes No
4. Diagnosis for use (indication) 5. Product Type (check all that apply) 6. Expiration Date (e.g., 01-Jan-1900)
OTC Generic
Compounded Biosimilar
7. Event Abated after use Stopped or Dose Reduced? 8. Event Reappeared after Reintroduction?
Yes No Doesn’t apply Yes No Doesn’t apply
SUSPECT PRODUCT #2
This report involves: Cosmetic Dietary supplement Food/medical food Other
1. Name, Strength, Manufacturer/Compounder (from product label).
Product Name Strength Unit
NDC # or Unique ID Manufacturer/ Compounder Name Lot #
2. Dose or Amount Frequency Route
Unit Other Frequency Other Route
3. Treament Dates/Therapy Dates (give best estimate of length of treatment (start/stop) or date of dose reduction.)
Therapy started on Therapy stopped on Dose reduced on OR Duration Unit
(e.g., 01-Jan-1900) (e.g., 01-Jan-1900) (e.g., 01-Jan-1900)
Is therapy still on-going? Yes No
4. Diagnosis for use (indication) 5. Product Type (check all that apply) 6. Expiration Date (e.g., 01-Jan-1900)
OTC Generic
Compounded Biosimilar
7. Event Abated after use Stopped or Dose Reduced? 8. Event Reappeared after Reintroduction?
Yes No Doesn’t apply Yes No Doesn’t apply
Form FDA-3500 (11/22) Page 3 of 6 (continued on next page)
E. SUSPECT MEDICAL DEVICE
1. Brand Name 2a. Common Device Name 2b. Procode
3. Manufacurer Name, City and State
4. Model # Lot # Catalog #
Expiration Date (e.g., 01-Jan-1900) Serial #
Unique Device Identifier (UDI) #
5. Operator of device
Health Professional Patient/Consumer Other
6a. If Implanted, Give Date (e.g., 01-Jan-1900) 6b. If Explanted, Give Date (e.g., 01-Jan-1900)
7a. Is this a single-use device 7b. If Yes to Item 7a, Enter Name, Address of Reprocessor 8. Was this device ever serviced
that was reprocessed and by a third-party servicer?
reused on a patient? Yes No Unknown
Yes No
F. OTHER (CONCOMITANT) MEDICAL PRODUCTS
1. Product names and therapy dates (Exclude treatment of event)
Product Name Therapy Start Date (e.g., 01-Jan-1900) Therapy End Date (e.g., 01-Jan-1900)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Form FDA-3500 (11/22) Page 4 of 6 (continued on next page)
G. REPORTER (See confidentiality section on next page)
1. Name and Address
Last Name First Name
Address
City State/Province/Region ZIP/Postal Code
Country
Phone # Email
2. Health Professional? 3. Occupation 4. Also Reported to:
Yes No Manufacturer/Compounder
User Facility
Distributor/Importer
5. If you do NOT want your identity disclosed to the manufacturer, please mark this box:
ADVICE ABOUT VOLUNTARY REPORTING
Detailed instructions available at:
[Link]
Report adverse events, product problems or product Report even if:
use errors with: • You’re not certain the product caused the event
• Medications(drugs or biologics) • You don’t have all the details
• Medical devices (including diabetes glucose-test kit, • Just fill in the sections that apply to your report
hearing aids, breast pumps, and many more) How to report:
• Combination products(medication & medical devices) • Use section D for all products except medical devices
• Blood transfusions, gene therapies, and human cells • Attach additional pages if needed
and tissue transplants (for example, tendons, bone, • Use a separate form for each patient
and corneas) • Report either to FDA or the manufacturer (or both)
• Special nutritional products(dietary supplements,
medical foods, infant formulas) How to submit report:
• Cosmetics (such as moisturizers, makeup, shampoos • To report by phone, call toll-free: 1-800-FDA (332)-
and conditioners, face and body washes, deodorants, 1088
nail care products, hair dyes and relaxers, and • To fax report: 1-800-FDA (332)-0178
tattoos) • To report online: [Link]/medwatch/[Link]
• Food (including beverages and ingredients added to If your report involves a serious adverse event with a
foods) device and it occurred in a facility outside a doctor’s
Report product problems – quality, performance or office, that facility may be legally required to report to
safety concerns such as: FDA and/or the manufacturer. Please notify the person
• Suspected counterfeit product in that facility who would handle such reporting.
• Suspected contamination
Where to submit adverse events related to the following
• Questionable stability
products:
• Defective components
• Poor packaging or labeling • If your report involves an animal drug, device, pet
food and livestock feed problems, go to
• Therapeutic failures (product didn’t work)
[Link]
Report SERIOUS adverse events. An event is serious
when the patient outcome is: • If your report involves a health problem or a product
problem with a tobacco product, go to
• Death
[Link] or call
• Life-threatening
1-877-287-1373 to report.
• Hospitalization (initial or prolonged)
• Disability or permanent damage • If your report involves an adverse event with a
vaccine, go to [Link] to report or call
• Congenital anomaly/birth defect
1-800-822-7967.
• Required intervention to prevent permanent
impairment or damage
• Other serious (important medical events)
Form FDA-3500 (11/22) Page 5 of 6
Confidentiality: Department of Health and Human Services
The patient’s identity is held in strict confidence by FDA Food and Drug Administration
and protected to the fullest extent of the law. The Office of Chief Information Officer
reporter’s identity, including the identity of a self-reporter, Office of Chief Information Officer
may be shared with the manufacturer unless requested Paperwork Reduction Act (PRA) Staff
otherwise. PRAStaff@[Link]
The information in this box applies only to requirements Please DO NOT RETURN this form to the PRA Staff
of the Paperwork Reduction Act of 1995 e-mail above.
The burden time for this collection of information has
been estimated to average 40 minutes per response, OMB statement:
including the time to review instructions, search existing “An agency may not conduct or sponsor, and a person is
data sources, gather and maintain the data needed, and not required to respond to, a collection of information
complete and review the collection of information. unless it displays a currently valid OMB control number.”
Send comments regarding this burden estimate or any U.S. DEPARTMENT OF HEALTH
other aspect of this collection of information, including AND HUMAN SERVICES
suggestions for reducing this burden to:
Form FDA-3500 (11/22) Page 6 of 6
