How to report an adverse event or device problem to FDA

FDA's MedWatch programme takes voluntary reports about drugs, biologics, medical devices, dietary supplements, cosmetics and foods. Reports from the public are one of the ways FDA learns about problems that did not show up in clinical studies.

Consumers and caregivers

• Online: MedWatch Online Voluntary Reporting Form (Form FDA 3500B, written for consumers).
• By phone: 1-800-FDA-1088 (1-800-332-1088), to request a form or ask how to report.
• By fax or post: download Form FDA 3500 from the MedWatch page and send it to the address on the form.
• Vaccines go to a separate system, VAERS, run jointly by FDA and CDC.

Health professionals

Form FDA 3500 online, by fax or by post, through the same MedWatch page. Hospitals, nursing homes and other user facilities must report device-related deaths to FDA and the manufacturer, and serious injuries to the manufacturer, on Form FDA 3500A within ten working days.

Reporting to the manufacturer

Manufacturers are required to forward reports they receive to FDA, so a report to the company (the phone number is on the label or packaging) reaches FAERS or MAUDE as a manufacturer report. Reporting to both is allowed; FDA links duplicates where it can.

What helps

The product name and, for devices, the model and lot number; what happened and when; the patient's age, sex and weight; other products being used; and whether the problem stopped when the product was stopped. Personal identifiers are protected: FDA does not publish reporter or patient identities, and openFDA removes the narrative text.

An emergency is not a reporting question. For someone who is unwell, contact a clinician or the local emergency number first.