BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE SLING

    MDR report key: 1004050 · Received February 25, 2008

    Report

    Report Number
    1645337-2008-00017
    Event Type
    Injury
    Date Received
    February 25, 2008
    Manufacturer
    MENTOR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH AN OBTAPE TRANSOBTURATOR SLING. SUBSEQUENTLY, AS REPORTED BY HER ATTORNEY, THE PT EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING. ALSO, HAD TO UNDERGO MULTIPLE SURGERIES AND SUSTAINED PERMANENT INJURY. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTAPE SLING TRANSOBTURATOR SLING FTL MENTOR 93-4000

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention