BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 5050334 · Received September 2, 2015

    Report

    Report Number
    2183959-2015-58578
    Event Type
    Death
    Date Received
    September 2, 2015
    Report Date
    August 16, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K011251
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED DIARRHEA, CONSTIPATION, PERSISTENT AND RECURRENT STRESS INCONTINENCE. FURTHERMORE, IT WAS ALSO REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581249 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death