BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX

    MDR report key: 5725523 · Received June 13, 2016

    Report

    Report Number
    MW5062860
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 27, 2016
    Manufacturer
    ENDOLOGIZ
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO YEARS STATUS POST ENDOLOGIX ENDOVASCULAR ANEURYSM REPAIR TYPE 3 LEAK WITH MAJOR STENT FRACTURES. A 8CC AAA NOW WITH TYPE 3 LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374353 ENDOLOGIX AFX DYB ENDOLOGIZ AFX

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R