BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONARC SLING SYSTEMS

    MDR report key: 1945884 · Received December 7, 2010

    Report

    Report Number
    2183959-2010-00446
    Event Type
    Other
    Date Received
    December 7, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 30, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES "MONARCH BLADDER SLING HAS CAUSED PAIN IN MY PELVIC ARE PAIN WITH SEX. URINE HAS BEGAN TO LEAK AGAIN. I HAVE TINGLING IN MY LEGS AND HANDS, UPPER BACK PAIN AND MAJOR HEADACHES." NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARC SLING SYSTEMS SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 72403830 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other