BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX

    MDR report key: 7071902 · Received November 30, 2017

    Report

    Report Number
    7071902
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    November 10, 2017
    Report Date
    November 14, 2017
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TYPE 3 ENDOLEAK. GRAFT RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852642 ENDOLOGIX POWERLINK MIH

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention