BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE SLING

    MDR report key: 1020575 · Received March 28, 2008

    Report

    Report Number
    1645337-2008-00024
    Event Type
    Injury
    Date Received
    March 28, 2008
    Report Date
    March 27, 2008
    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, AS REPORTED BY HER ATTORNEY, THE PT EXPERIENCED SERIOUS PERSONAL INJURIES, INCLUDING BUT NOT LIMITED TO INFECTION AND EROSION OF BODILY TISSUES. NO OTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention