Medical device reporting is a mechanism for the FDA to obtain vital medical device adverse events from device manufacturers, user facilities and importers. This is done for the purpose of the detecting and correcting such reported adverse events quickly. As a health care professional or consumer, you are required to use the nearby link to the MedWatch program to report vital adverse events or medical device defects.
User facilities include nursing homes and hospitals. All suspected medical device related deaths and serious injuries must be reported by the user facilities. As per the Safe Medical Devices Act of 1990 (SMDA), medical device user facilities should report device associated deaths to the FDA and manufacturer when identified. Device related serious injuries must also be reported to the manufacturer and FDA.