BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 3082902 · Received April 22, 2013

    Report

    Report Number
    1645337-2013-00129
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH AN OBTAPE TRANSOBTURATOR SLING. SUBSEQUENTLY, ACCORDING TO THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED PAIN, EROSION, URINARY DIFFICULTIES, INFECTION AND DYSPAREUNIA. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172996 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR OTN MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other