BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 5454473 · Received February 23, 2016

    Report

    Report Number
    3011770902-2016-00085
    Event Type
    Death
    Date Received
    February 23, 2016
    Report Date
    September 23, 2014
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED 12/23/2014 UNDER EXEMPTION E2013032

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED AN UNSPECIFIED INJURY. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH WAS REPORTED AS SUDDEN CARDIAC DEATH DUE TO CORONARY ARTERY DISEASE. RELATED TO MFR # 3011770902-2016-00084, 3011770902-2016-00086.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111375 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ELEVATE ANTERIOR| ELEVATE POSTERIOR| ELEVATE ANTERIOR