BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING ELECTRODE 1

    MDR report key: 3074250 · Received April 8, 2013

    Report

    Report Number
    3074250
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    ELECTRODE WAS PLACED AND WAS NOT WORKING PROPERLY. A NEW ELECTRODE WAS GIVEN TO THE STERILE FIELD FOR USE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144428 MICROTARGETING ELECTRODE 1 ELECTRODE, DEPTH GZL FHC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR