BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 2944640 · Received February 5, 2013

    Report

    Report Number
    2031527-2012-00145
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49531 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100-O20 1032435-019

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention