BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE VAGINAL MESH

    MDR report key: 3934582 · Received July 10, 2014

    Report

    Report Number
    MW5037251
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 9, 2014
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD PREVIOUS GYNECARE MESH PLACEMENT AND DEVELOPED SIGNIFICANT VAGINAL PAIN DUE TO THIS. SHE DESIRED SURGICAL REMOVAL OF ANTERIOR VAGINAL MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402512 GYNECARE VAGINAL MESH VAGINAL MESH OTN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R