BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS MONARC SLING SYSTEM

    MDR report key: 3910044 · Received June 11, 2014

    Report

    Report Number
    2183959-2014-18597
    Event Type
    Death
    Date Received
    June 11, 2014
    Report Date
    August 19, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K023516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, EMOTIONAL DISTRESS AND A PRODUCT PROBLEM. 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
    344955 AMS MONARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death