BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 5834273 · Received July 29, 2016

    Report

    Report Number
    1645337-2016-00071
    Event Type
    Injury
    Date Received
    July 29, 2016
    Report Date
    July 21, 2016
    Manufacturer
    MENTOR WW LLC
    Product Code
    PAH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    MENTOR HAS BEEN IN THE PROCESS OF TRYING TO OBTAIN EMDR APPROVAL FOR 4 MONTHS. NOT RETURNED.

    Description of Event or Problem · 1

    INJURIES. (LITIGATION CASE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485589 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR PAH MENTOR WW LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other