BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 2091493 · Received May 6, 2011

    Report

    Report Number
    2183959-2011-00157
    Event Type
    Injury
    Date Received
    May 6, 2011
    Report Date
    April 20, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES A SPARC SLING WAS IMPLANTED ON (B)(6) 2006. SINCE THE IMPLANT, THE PT REPORTEDLY EXPERIENCED PAIN, EROSION OF MESH INTO BLADDER, URINARY URGENCY AND FREQUENCY, DYSPAREUNIA, AND HAD A BLADDER STONE FORMATION.

    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 Other| S