BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS SPARCE SLING SYSTEM

    MDR report key: 4901131 · Received July 7, 2015

    Report

    Report Number
    2183959-2014-16467
    Event Type
    Death
    Date Received
    July 7, 2015
    Date of Event
    February 16, 2011
    Report Date
    September 16, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K011251
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED (B)(4), 2014 UNDER EXEMPTION (B)(4). ADDITIONALLY, THIS WAS REPORTED ON THE SUMMARY REPORT DATED (B)(4), 2015 UNDER EXEMPTION (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, MIXED INCONTINENCE, OVERACTIVE BLADDER, AND URGE INCONTINENCE. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440165 AMS SPARCE SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death