BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 2960441 · Received January 30, 2013

    Report

    Report Number
    1645337-2013-00023
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MENTOR TEXAS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH AN OBTAPE TRANSOBTURATOR SLING. SUBSEQUENTLY, ACCORDING TO THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED EROSION AND BLEEDING. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40162 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR FTL MENTOR TEXAS, INC. AD080057

    Patients

    Seq Age Sex Outcome Treatment
    1 Other