BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 5538461 · Received March 31, 2016

    Report

    Report Number
    3011770902-2016-00148
    Event Type
    Death
    Date Received
    March 31, 2016
    Report Date
    March 27, 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 Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED 6/30/2014 UNDER EXEMPTION E2013032

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED PAIN AND SUFFERING, MENTAL ANGUISH, EMOTIONAL DISTRESS, DISFIGUREMENT, PHYSICAL IMPAIRMENT, EMBARRASSMENT AND HUMILIATION, PSYCHOLOGICAL INJURY, A REASONABLE AND TRAUMATIC FEAR OF AN INCREASED RISK OF ADDITIONAL INJURIES, PROGRESSION OF EXISTING CONDITIONS, OTHER SERIOUS INJURY AND LOSS, AND A PRODUCT PROBLEM. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH WAS REPORTED ASS AMYOTROPHIC LATERAL SCLEROSIS. RELATED TO MFR # 3011770902-2016-00146, 3011770902-2016-00147.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193584 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MINIARC PRECISE| MONARC| MONARC