BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 2960389 · Received February 1, 2013

    Report

    Report Number
    1645337-2013-00028
    Event Type
    Injury
    Date Received
    February 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    OTN
    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 SUFFERED SERIOUS AND PERMANENT BODILY INJURIES, INCLUDING EROSION OF THE OBTAPE MEDICAL DEVICE THROUGH HER INTERNAL BODILY TISSUES, CHRONIC INFECTIONS, PAIN, EXACERBATION OF HER URINARY INCONTINENCE, AND THE NEED FOR ADDITIONAL SURGICAL PROCEDURES AND MEDICAL TREATMENT AS WELL AS THE NEED FOR EXTENSIVE FUTURE MEDICAL CARE. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43740 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR OTN MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other