BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 2190256 · Received July 18, 2011

    Report

    Report Number
    1645337-2011-00019
    Event Type
    Injury
    Date Received
    July 18, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MENTOR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 SERIOUS BODILY INJURY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAVE REQUIRED MULTIPLE SURGERIES, AND HAVE SUSTAINED PERMANENT INJURY AND OTHER DAMAGES. NO OTHER INFORMATION 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