BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SUBFASCIAL HAMMOCK

    MDR report key: 1923566 · Received December 10, 2010

    Report

    Report Number
    2183959-2010-00453
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND REASON PROMPTING THIS EVENT WAS NOT PROVIDED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BECOME AVAILABLE REGARDING A REVISION SURGERY, IT WILL BE RE-EVALUATED AND A F/U REPORT SENT.

    Description of Event or Problem · 1

    IN (B)(6) 2008, A MONARC DEVICE WAS IMPLANTED IN A FEMALE PT TO TREAT STRESS URINARY INCONTINENCE. THIS PT STATES, SHE INFORMED HER SURGEON SHE WAS HAVING SOME PROBLEMS AND SHE THOUGH IT MAY BE FROM THE IMPLANT. THE PT BELIEVES THE MESH WAS MALPOSITIONED, AND SHOULD BE REMOVED. PT NOW HAS EXTRUSION OF MESH THROUGH THE VAGINAL WALL AND HAS HAD ADD'L PROCEDURES TO REVISE THE MESH. THE PT STATES SHE HAS EXTENSIVE PAIN, DISFIGUREMENT, EMOTIONAL DISTRESS, AND LOSS OF ENJOYMENT AND BELIEVES SHE WILL NEED ADD'L PROCEDURES IN THE FUTURE TO TREAT THIS. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARC SUBFASCIAL HAMMOCK NONE FTL AMERICAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability