BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 2196545 · Received August 3, 2011

    Report

    Report Number
    2183959-2011-00285
    Event Type
    Injury
    Date Received
    August 3, 2011
    Report Date
    July 22, 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 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

    RELATED TO MFR REPORT # 2182959-2011-00284 AND MFR REPORT # 2183959-2011-00286. ON (B)(6), 2008, A MONARC SLING DEVICE WAS IMPLANTED TO TREAT PELVIC ORGAN PROLAPSE. "AFTER, AND AS A RESULT OF IMPLANTATION," THE PATIENT EXPERIENCED, "BODILY INJURIES" INCLUDING EXTREME PAIN, RECURRENT INFECTIONS, EROSION OF INTERNAL BODY TISSUES, DYSPAREUNIA AND "OTHER INJURIES" THAT ARE ONGOING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability PERIGEE| APOGEE