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# Most MDRs Hit Device Function Issues: Study
- URL: https://www.fdaweb.com/most-mdrs-hit-device-function-issues-study/
- Published: 2024-03-12T12:00:00.000Z
- Updated: 2026-09-14T14:25:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156531

FDA and Instem researchers say their review of more than 10 million Medical Device Reports (MDRs) in the MAUDE (Manufacturer and User Facility Device Experience) database filed between 2011 and 2021 found that about 92% of reported issues represented medical device physical or functional failures rather than adverse events. Writing in *Regulatory Toxicology and Pharmacology*, the researchers [note](https://www.sciencedirect.com/science/article/abs/pii/S0273230024000321?via%3Dihub&ref=fdaweb.com) the number of MDRs increased almost five-fold over the study period. A large segment of the submissions fell into the area of diagnostics, they say, which were not followed further in the study due to its focus on medical devices with direct patient contact.

The evaluation also found some differences in patient responses, including sex-based differences. “While the mechanisms for the observed reporting differences remain unclear,” the study concludes, “our findings may contribute to improving focus on certain clinical classes or types of medical devices.”