BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE TRANSOBTURATOR SLING

    MDR report key: 3901536 · Received June 18, 2014

    Report

    Report Number
    1645337-2014-00099
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SERIOUS AND BODILY PERMANENT INJURIES INCLUDING BUT NOT LIMITED TO PAIN, CHRONIC INFECTIONS, EXACERBATION OF HER INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358419 OBTAPE TRANSOBTURATOR SLING TRANSOBTURATOR OTN MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other