Considerable Proportion of Medical Device Adverse Events Reported Late
THURSDAY, March 13, 2025 -- Although most manufacturer reports of medical device adverse events are reported on time, a considerable proportion are submitted late, according to a study published online March 12 in The BMJ.
Alexander O. Everhart, Ph.D., from the Washington University School of Medicine in St. Louis, and colleagues conducted a cross-sectional study to describe the extent of late adverse event reporting by manufacturers to the U.S. Food and Drug Administration Manufacturer And User Facility Device Experience (MAUDE) database. Data were included from medical device manufacturers that submitted initial adverse event reports between Sept. 1, 2019, and Dec. 31, 2022.
The researchers identified 13,587 reports of deaths, 1,552,268 reports of injuries, and 2,866,693 reports of malfunctions received from 3,028 unique manufacturers and 88,448 unique medical devices during the study period. Overall, 71.0 percent of adverse events were reported within 30 days (on time), while 4.5 and 9.1 percent were reported between 31 and 180 days or after 180 days, respectively (both late). Missing or invalid data were provided by the manufacturer in 15.5 percent of reports. More than half (54.8 percent) of late reports were attributable to three manufacturers and 13 medical devices.
"MAUDE is an incomplete data source for understanding medical device safety issues, due partly to the timeliness of its reports," the authors write.
Several authors disclosed ties to the medical device and health care industries; one author disclosed being an expert witness.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
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