BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 2234098 · Received August 29, 2011

    Report

    Report Number
    1645337-2011-00022
    Event Type
    Injury
    Date Received
    August 29, 2011
    Report Date
    August 24, 2011
    Manufacturer
    MENTOR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR FTL MENTOR 93-4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention