BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOLOGIX

    MDR report key: 3143243 · Received January 24, 2013

    Report

    Report Number
    3143243
    Date Received
    January 24, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE GRAFT DEPLOYED OUT OF THE SHEATH BEFORE DR. (B)(6) INTENTIONALLY DEPLOYED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35373 ENDOLOGIX A SUPER RENAL AORTIC CUFF MIH ENDOLOGIX A25-25/C75-020

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization