August 2nd, 2021

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Analysis of the Food and Drug Administration MAUDE Database for Approved Devices in Obstetrics and Gynecology
Authors:  Joseph M. Maurice, M.D., M.S., FACOG, and Sheena Galhotra, M.D.
  OBJECTIVE: To evaluate the accuracy of the Manufacturer and User Facility Device Experience (MAUDE) database for devices approved via premarket (PMA) and 510(k) approval processes, and to compare the accuracy of death and injury reports.

STUDY DESIGN: A retrospective observational study.

RESULTS: Death and injury reports were collected from November 1, 2002, to April 25, 2018, from the MAUDE database. This collection of raw data was subsequently adjusted to improve accuracy. There was an 87% drop in number of adjusted death reports as compared to raw death reports (p=0.004). There was a 98% drop in the number of adjusted injury reports as compared to raw injury reports (p=0.002).

CONCLUSION: Death reports in the MAUDE database are more accurate than injury reports, whether approved by the PMA or 510(k) process, and more likely to contain an actual death, as compared to an actual injury report. Raw death reports overestimated deaths 7.9 times as compared to adjusted death reports; injury reports overestimated total injuries by 71.9 times as compared to adjusted injury reports. This warrants a call for a more accurate national device registry with concurrent robust statistical analysis so trends of potentially harmful devices can be identified.
Keywords:  equipment and supplies, FDA, MAUDE Database, medical device, public health, public health service, registries, USFDA, USPHS, United States Food and Drug Administration, United States Public Health Service
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