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KMID : 1011820180590020126
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Investigative and Clinical Urology
2018 Volume.59 No. 2 p.126 ~ p.132
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An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh
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Sandberg Jason M.
Gray Ian
Pearlman Amy M.
Terlecki Ryan P.
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Abstract
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Purpose: To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States.
Materials and Methods: We reviewed 1,103 individual medical device reports submitted to the MAUDE database that inspired the United States (US) Food and Drug Administration's 2008 Public Health Notification. Entries were compiled into a categorical database that reported manufacturer, brand, reporter type, report source, and type of adverse event.
Results: There were numerous examples of missing, duplicated, and non-standardized entries. Analysis revealed 64 reports with duplicated information, and six reports representing multiple patients. Forty-seven percent of medical device reports did not identify a reporter source. At least 28% of reported devices are no longer on the US market. There was wide variability in the quality and completeness of submitted reports and true adverse event rates could not be accurately calculated because the number of total cases was unknown.
Conclusions: The MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh. While it functions to collect information related to isolated adverse events, systematic limitations of the MAUDE database, that no doubt extend to other medical devices, necessitate the development of new reporting systems. Alternatives are under development, which may allow regulators to more accurately scrutinize the safety profiles of specific medical devices.
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KEYWORD
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Equipment safety, Registries, Surgical mesh, United States Food and Drug Administration
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