Understanding Variation Among Medical Device Reporting Sources: A Study of the MAUDE Database.

Abstract

Increasing medical device usage raises concerns regarding unexpected, potentially life-threatening events that pose public health risks. Such events are reported to the Food and Drug Administration (FDA), and cataloged in the Manufacturer and User Facility Device Experience (MAUDE) database, a vital tool for post market surveillance that requires information of high quality and integrity, particularly concerning reporting sources. To analyze reporting behavior among different reporters, includin