BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS MINIARC PRECISE SINGLE-INCISION SLING

    MDR report key: 4934451 · Received July 21, 2015

    Report

    Report Number
    2183959-2014-15166
    Event Type
    Death
    Date Received
    July 21, 2015
    Report Date
    September 23, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    PAH
    PMA / PMN Number
    K100807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS INITIALLY REPORTED ON SUMMARY REPORT DATED (B)(4) 2014 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, INFECTION, DISCOMFORT, RECURRENCE, EMOTIONAL DISTRESS AND A PRODUCT PROBLEM. 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
    470804 AMS MINIARC PRECISE SINGLE-INCISION SLING MESH, SURGICAL, POLYMERIC PAH AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death