BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 2960446 · Received January 30, 2013

    Report

    Report Number
    1645337-2013-00015
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MENTOR WORLDWIDE LLC
    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 A HIGH ABSCESS. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39948 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR FTL MENTOR WORLDWIDE LLC AE030061

    Patients

    Seq Age Sex Outcome Treatment
    1 Other