BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 2684271 · Received August 2, 2012

    Report

    Report Number
    2183959-2012-01563
    Event Type
    Injury
    Date Received
    August 2, 2012
    Report Date
    July 9, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT ON OR ABOUT (B)(6) 2006, THE PLAINTIFF WAS IMPLANTED WITH A MONARC SLING SYSTEM "WITH THE INTENTION OF TREATING THE PLAINTIFF FOR STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE." IT WAS ALLEGED THAT THE PLAINTIFF HAS "SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME PAIN, EROSION OF HER INTERNAL BODILY TISSUE, CONTINUAL BLADDER AND URETHRA INFECTIONS," HAS "EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING," HAS "REQUIRED ADDITIONAL SURGERY AND MEDICAL TREATMENT AND SHE HAS SUSTAINED PERMANENT INJURY," "WAS INJURED IN HER HEALTH, STRENGTH, AND ACTIVITY, SUSTAINING INJURY TO HER PERSON, ALL OF WHICH INJURIES HAVE CAUSED PLAINTIFF SEVERE MENTAL AND PHYSICAL PAIN AND SUFFERING," HAS "SUSTAINED PERMANENT INJURY," "HAS UNDERGONE MEDICAL TREATMENT," AND HAS HAD "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 Hospitalization| R| S