BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 2954225 · Received February 7, 2013

    Report

    Report Number
    1645337-2013-00037
    Event Type
    Injury
    Date Received
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 SEVERE PERMANENT BODILY INJURIES, EROSION, CHRONIC INFECTIONS, PAIN, URINARY INCONTINENCE AND MULTIPLE ADDITIONAL SURGICAL PROCEDURES AND MEDICAL TREATMENT AS WELL AS THE NEED FOR EXTENSIVE FUTURE MEDICAL CARE. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51591 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR FTL MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other