BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 2823833 · Received October 29, 2012

    Report

    Report Number
    2183959-2012-02921
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    August 16, 2010
    Report Date
    October 5, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    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# 2183959-2012-02922. IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH A MONARC ON OR ABOUT (B)(6) 2005 WITH THE INTENTION OF TREATING HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. IT WAS ALLEGED THAT THE PLAINTIFF SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME PAIN, EROSION OF HER INTERNAL BODILY TISSUE, MESH EROSION, WORSENING DYSPAREUNIA, HARDENING, RECURRENT INCONTINENCE, AND OTHER INJURIES. ADDITIONALLY, THE PLAINTIFF EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, PERMANENT INJURY. THE PLAINTIFF UNDERWENT ADDITIONAL SURGERY ON OR ABOUT (B)(6) 2010.

    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 Hospitalization| R| S PERIGEE GRAFT SYSTEM