Whenever you think a medical product may be associated with a serious event (seizure, bronchospasm, GI bleed, hospitalization, life-threatening illness, disability, congenital anomaly, etc.) You need not be sure about causality; if you suspect the product is associated with a serious event, FDA is interested.

Reporting is easier than you think. Although the form asks for many details, the only required info is the product and a description of the problem.

Your report might be the vital action that prompts a change in drug design, identifies unsuspected drug toxicity, or leads to safer use for patients.

Anyone can report a serious adverse event that may be associated with a medical product or device.

It takes only minutes. There are 4 ways to report: secure online forms available at the links to the right; one-page fax or mail form, or phone 1-800-FDA-1088.

FDA has created a safe environment for sharing patient data for public health surveillance. HIPAA allows for reporting of adverse events to FDA without patient authorization. No follow-up from FDA or manufacturers is required; reporting is not an admission of fault.