BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEMS

    MDR report key: 1251692 · Received December 2, 2008

    Report

    Report Number
    2183959-2008-00027
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 18, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WHO WAS IMPLANTED WITH SPARC HAS GRAFT EXTRUSION, BLADDER INFECTIONS AND PAIN. SHE WAS PRESCRIBED PYRIDIUM AND MACRODANTIN. ORIGINAL IMPLANT DATE UNKNOWN. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPARC SLING SYSTEMS SPARC/OTHER SLING TYPES FTL AMERICAN MEDICAL SYSTEMS, INC. 72403656 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability