BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCE SLING SYSTEMS

    MDR report key: 1258162 · Received December 3, 2008

    Report

    Report Number
    2183959-2008-00026
    Event Type
    Other
    Date Received
    December 3, 2008
    Date of Event
    November 3, 2008
    Report Date
    December 2, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH ADVANCE SLING IN 2008 AND SAID, HE IS HAVING A LOT OF PAIN IN THE PELVIC/SCROTAL AREA. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE SLING SYSTEMS ADVANCE/OTHER SLING TYPES FTL AMERICAN MEDICAL SYSTEMS, INC. 72404223

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability