BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLING SYSTEM

    MDR report key: 2123134 · Received June 10, 2011

    Report

    Report Number
    2183959-2011-00186
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    March 1, 2009
    Report Date
    May 23, 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

    AMS BELIEVES THE "AMS MESH/SLING PRODUCT" REFERENCED IS MOST LIKELY EITHER A MONARC OR A SPARC SURGICAL MESH. 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

    IT WAS REPORTED THAT AN "AMS MESH/SLING PRODUCT" WAS IMPLANTED, DATE NOT INDICATED. "ON ABOUT (B)(6) 2009" THE PATIENT "UNDERWENT TRANSVAGINAL TAPE, BLADDER SLING, URETHRAL SUSPENSION, AND REVISION OF MESH EROSION REPAIR" BECAUSE SINCE IMPLANTATION THE PATIENT REPORTS "EROSION, SHRINKAGE, AND EXTRUSION OF MESH FROM ONE OR MORE OF THE MESH DEVICES, CAUSING URINARY RETENTION, SEVERE PERSISTENT PAIN, INCLUDING DYSPAREUNIA, AND "NUMEROUS SURGICAL PROCEDURES TO REMOVE THE MESH DEVICES."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S