BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE SLING

    MDR report key: 1033829 · Received April 24, 2008

    Report

    Report Number
    1645337-2008-00027
    Event Type
    Injury
    Date Received
    April 24, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MENTOR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 EROSION OF INTERNAL TISSUE INCLUDING EROSION THROUGH THE VAGINAL WALLS. 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