BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 2800837 · Received October 17, 2012

    Report

    Report Number
    2183959-2012-02880
    Event Type
    Injury
    Date Received
    October 17, 2012
    Report Date
    September 26, 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 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 MONARCH SUBFASCIAL HAMMOCK ON OR ABOUT (B)(6) 2008 TO TREAT HER STRESS URINARY INCONTINENCE. IT WAS ALLEGED THE PLAINTIFF SUFFERED SERIOUS BODILY INJURIES, INCLUDING EXTREME PAIN, BLADDER SPASMS, CONTINUED URINARY INCONTINENCE, AND EROSION OF HER INTERNAL BODILY TISSUE. IT WAS ADDITIONALLY REPORTED THE PLAINTIFF EXPERIENCED SUFFERING, PERMANENT DISABILITY, INCLUDING PERMANENT INSTABILITY AND LOSS OF BALANCE.

    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