BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 4897917 · Received July 6, 2015

    Report

    Report Number
    2183959-2014-14025
    Event Type
    Death
    Date Received
    July 6, 2015
    Date of Event
    September 26, 2008
    Report Date
    July 12, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K023516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED (B)(6) 2014 UNDER EXEMPTION (B)(4). ADDITIONALLY THIS WAS REPORTED ON THE SUMMARY REPORT (B)(4). LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, EROSION, SUFFERING, MENTAL ANGUISH, DISFIGUREMENT, PHYSICAL IMPAIRMENT, INFECTION, URINARY AND BOWEL PROBLEMS, BLEEDING, VAGINAL SCARRING, EMOTIONAL DISTRESS, PRODUCT PROBLEM AND OTHER UNSPECIFIED INJURY. THE PLAINTIFF ALSO EXPERIENCE VAGINAL MESH EXTRUSION. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MFR REPORT # 2183959-2014-14692, -54619.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435696 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death APOGEE| PERIGEE| PERIGEE| APOGEE