BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 2893938 · Received December 21, 2012

    Report

    Report Number
    1645337-2012-00233
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    December 21, 2012
    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 EROSION, INFECTIONS, PAIN AND URINARY INCONTINENCE. NO OTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other