BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR

    MDR report key: 1120884 · Received August 15, 2008

    Report

    Report Number
    1645337-2008-00044
    Event Type
    Injury
    Date Received
    August 15, 2008
    Report Date
    August 13, 2008
    Manufacturer
    MENTOR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH AN OBTAPE TRANSOBTURATOR. SUBSEQUENTLY, PER HER ATTORNEY, THE PT EXPERIENCED SERIOUS BODILY INJURIES. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTAPE TRANSOBTURATOR TRANSOBTURATOR SLING FTL MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other