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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

Sandberg J, Gray I, Pearlman A, Terlecki R

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...
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