BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 2960404 · Received February 1, 2013

    Report

    Report Number
    1645337-2013-00020
    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 SIGNIFICANT MENTAL AND PHYSICAL PAIN, INCLUDING BUT NOT LIMITED TO, CONTINUED INCONTINENCE, EXTREME PAIN, EROSION OF HER INTERNAL BODY TISSUE, CONTINUAL BLADDER AND URETHRA INFECTIONS AND OTHER PERMANENT INJURIES. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43566 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR OTN MENTOR WORLDWIDE LLC 040723E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other