Reporting Serious Problems to FDA
Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can also report suspected counterfeit medical products to FDA through MedWatch.
In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of these products. Your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.
Voluntary Reporting for Consumers and Healthcare Professionals
- Report a Serious Medical Product Problem Online
Report product quality problems, adverse reactions, product use errors, or therapeutic failure.
- Consumer-Friendly Voluntary Reporting Form (PDF - 1.2MB)
- Health Professional Voluntary Reporting Form (PDF - 1.6MB)
- Information on Reporting by Consumers
- Information on Reporting By Health Professionals
Teaching students, health professionals, and consumers how to report problems to FDA