BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARGINPROBE

    MDR report key: 5418676 · Received February 9, 2016

    Report

    Report Number
    5418676
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    November 5, 2015
    Report Date
    January 18, 2016
    Manufacturer
    DUNE MEDICAL DEVICES INC.
    Product Code
    OEE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NURSES CONNECTED THE MARGIN PROBE TO THE MACHINE AS INSTRUCTED BY THE SURGEON . INITIALLY IT SEEMED TO WORK, AND THEN THE SCREEN SHOWED "FAILURE". MANUFACTURER RESPONSE FOR DUNN MARGIN PROBE X 2, DUNN (PER SITE REPORTER): THE REP WAS HERE TO CHECK THE MACHINE AND SEE IF THIS WAS THE ISSUE OR THE HAND PIECES AND IF THE MACHINE WAS WORKING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76622 MARGINPROBE DIAGNOSTIC LOW ELECTRIC FIELD OEE DUNE MEDICAL DEVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER THERAPIES