BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 3981391 · Received July 24, 2014

    Report

    Report Number
    1645337-2014-00114
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EXTENSIVE AND MULTIPLE INFECTIONS, BLEEDING, EROSION OF THE MESH AND INTERNAL/EXTERNAL SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435404 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR OTN MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other