BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS MONARC+ SUBFASCIAL HAMMOCK

    MDR report key: 5021319 · Received August 21, 2015

    Report

    Report Number
    2183959-2014-73313
    Event Type
    Death
    Date Received
    August 21, 2015
    Report Date
    September 23, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K051530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED DECEMBER 23, 2014 UNDER EXEMPTION (B)(4). LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED AN UNSPECIFIED INJURY. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH REPORTED WERE ACUTE RESPIRATORY DISTRESS SYNDROME, CYTOMEGALOVIRUS, AND IMMUNOSUPPRESSION FOR PSORIASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553701 AMS MONARC+ SUBFASCIAL HAMMOCK MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death