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

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...

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Detalles Bibliográficos
Autores principales: Sandberg, Jason M., Gray, Ian, Pearlman, Amy, Terlecki, Ryan P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Urological Association 2018
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5840117/
https://www.ncbi.nlm.nih.gov/pubmed/29520389
http://dx.doi.org/10.4111/icu.2018.59.2.126

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5840117/
https://www.ncbi.nlm.nih.gov/pubmed/29520389
http://dx.doi.org/10.4111/icu.2018.59.2.126

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