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PubMed

Understanding Variation Among Medical Device Reporting Sources: A Study of the MAUDE Database.

PMID: 39516116 ·

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RevistaClinical therapeutics
Ano
PMID39516116

Resumo

Increasing medical device usage raises concerns regarding unexpected, potentially life-threatening events that pose public health risks. Such events are reported to the Food and Drug Administration (FDA), and cataloged in the Manufacturer and User Facility Device Experience (MAUDE) database, a vital tool for post market surveillance that requires information of high quality and integrity, particularly concerning reporting sources. To analyze reporting behavior among different reporters, includin

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