BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 5243467 · Received November 23, 2015

    Report

    Report Number
    2183959-2015-00522
    Event Type
    Death
    Date Received
    November 23, 2015
    Report Date
    September 5, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774123 AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ELEVATE ANTERIOR| OBTRYX TRANSOBTRURATOR MID-URETHRAL SLING SYSTEM