Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA. Voluntary reporting can help FDA identify unknown risk for approved medical products. Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (Health Professional) or 3500B (Consumer/Patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.| www.accessdata.fda.gov
The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years. Reports older than ten years are provided on the FDA's MDR Data Files webpage. | www.accessdata.fda.gov