BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 2831760 · Received November 9, 2012

    Report

    Report Number
    2183959-2012-02990
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    July 1, 2009
    Report Date
    October 16, 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

    (B)(4). SHOULD ADDITIONAL INFO 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 THE PLAINTIFF WAS IMPLANTED WITH A MONARC ON OR ABOUT (B)(6) 2006 TO TREAT PELVIC VAULT PROLAPSE. IT WAS ALLEGED THE PLAINTIFF SUFFERED AND WILL CONTINUE TO SUFFER DISABILITY, IMPAIRMENT, FECAL INCONTINENCE, WORSENING URINARY INCONTINENCE, PELVIC AND ABDOMINAL PAIN, RECURRENT URINARY TRACT INFECTIONS, DYSPAREUNIA, BLEEDING FROM THE VAGINA AND RECTUM, FOUL SMELLING URINE, FREQUENCY AND URGENCY, LOSS OF ENJOYMENT OF LIFE, AND AN INABILITY TO ENGAGE IN CHOSEN AND NECESSARY ACTIVITIES. IN (B)(6) 2009, THE PLAINTIFF WAS HOSPITALIZED FROM A SEVERE KIDNEY AND URINARY TRACT INFECTION.

    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