Evaluation of reporting trends in the MAUDE Database: 1991 to 2022.

Abstract

Adverse event reporting for medical devices is critical for risk mitigation. The Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database serves as a key tool for post-market surveillance, receiving reports from various sources. Ensuring information integrity, especially across diverse reporting sources, is paramount. Periodic regulatory updates aim to enhance reporting. Analyze reporting patterns, assess the potential contribution of 2015 and 2018 r