BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 2181324 · Received July 21, 2011

    Report

    Report Number
    2183959-2011-00270
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2008, A SPARC SLING WAS IMPLANTED TO TREAT URINARY STRESS INCONTINENCE. "AFTER AND AS A RESULT OF IMPLANTATION," THE PT EXPERIENCED BLEEDING, VAGINAL IRRITATION, SCARRING, DYSPAREUNIA, URINARY STRESS INCONTINENCE, EXTREME PAIN ON URINATION, EROSION OF INTERNAL BODILY TISSUE AND "OTHER INJURIES." IT WAS REPORTED THAT THE PT HAD THREE REVISION SURGERIES TO CORRECT "THESE PROBLEMS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S