BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 3192019 · Received June 20, 2013

    Report

    Report Number
    2183959-2013-00851
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    September 1, 2009
    Report Date
    January 10, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. LAWYER-FILED REPORT - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH A MONARC ON OR ABOUT (B)(6) 2009 TO TREAT STRESS URINARY INCONTINENCE. IT WAS ALLEGED THE PLAINTIFF SUFFERED SERIOUS BODILY INJURIES, INCLUDING URINARY PROBLEMS, NEUROMUSCULAR PROBLEMS, VAGINAL DYSFUNCTION, PERSISTENT LEG PAIN, DYSPAREUNIA, EROSION AND WAS REQUIRED TO UNDERGO ADD'L MEDICAL PROCEDURES. IN (B)(6) 2009 THE PLAINTIFF FIRST PRESENTED TO HER DOCTOR WITH PAIN AND RELATED SYMPTOMS. AGAIN IN (B)(6) 2009 THE PLAINTIFF COMPLAINED OF THE SAME PAIN AND RELATED SYMPTOMS. ON OR ABOUT (B)(6) 2010 THE PLAINTIFF UNDERWENT SURGERY. IT WAS NOTED THAT THE PLAINTIFF UNDERWENT A CYSTOSCOPY EXAMINATION UNDER ANESTHESIA. A REVISION OF THE LEFT SLING ARM AND TRIGGER POINT INJECTIONS WERE DONE. ON OR ABOUT (B)(6) 2012, THE PLAINTIFF FURTHER UNDERWENT AN ADD'L SURGERY. REMOVAL OF THE RIGHT ARM SLING, AND INJECTIONS OF THE LEFT OBTURATOR TRIGGER POINT WERE PERFORMED. AS A RESULT, PLAINTIFF EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING. THE PLAINTIFF HAS REQUIRED ADD'L MEDICAL TREATMENT FOR CONTINUED INCONTINENCE, AND HAS SUSTAINED PERMANENT INJURIES AND DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281250 MONARC SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R| S