BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS MINIARC PRECISE SINGLE-INCISION SLING

    MDR report key: 3910016 · Received June 11, 2014

    Report

    Report Number
    2183959-2014-23575
    Event Type
    Death
    Date Received
    June 11, 2014
    Report Date
    April 3, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    PAH
    PMA / PMN Number
    K100807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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 PAIN, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, AND DYSPAREUNIA. IT WAS ALSO REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH WAS NOT REPORTED. RELATED TO MANUFACTURER REPORT # 2183959-2014-16474, 16476.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346131 AMS MINIARC PRECISE SINGLE-INCISION SLING MESH, SURGICAL, POLYMERIC PAH AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ELEVATE POSTERIOR| ELEVATE ANTERIOR