BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 2142341 · Received June 20, 2011

    Report

    Report Number
    2183959-2011-00215
    Event Type
    Injury
    Date Received
    June 20, 2011
    Report Date
    June 8, 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

    ON OR ABOUT (B)(6) 2007, A MINIARC PRECISE DEVICE WAS IMPLANTED TO TREAT "PELVIC ORGAN PROLAPSE." REPORTEDLY, "AFTER, AND AS A RESULT OF IMPLANTATION, THE PATIENT EXPERIENCED EXTREME PAIN, EROSION OF HER INTERNAL TISSUES, HEMATURIA, SCARRING, ADHESIONS AND OTHER INJURIES."

    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