Category

Adverses Events

Adverses Events

By Adverses Events, FDA News

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.  To learn more about how to report an adverse event, please visit the FDA website for updated information.