BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX

    MDR report key: 1258488 · Received December 1, 2008

    Report

    Report Number
    MW5009142
    Event Type
    Injury
    Date Received
    December 1, 2008
    Date of Event
    November 19, 2008
    Report Date
    December 1, 2008
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOLOGIX GRAFT TORE HOLE IN ILIAC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOGIX NONE MIH 25-16-120BL W080199
    2 ENDOLOGIX NONE MIH W080149

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability