BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3148960 · Received May 13, 2013

    Report

    Report Number
    3148960
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING RADIOFREQUENCY PROCEDURE THE PATIENT SUSTAINED BURN TO LEFT UPPER THIGH. UNDER GROUNDING PAD PLACEMENT, BURN WAS A 1ST DEGREE BURN SURROUNDED BY A 3RD DEGREE BURN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211403 * PROBE, RADIOFREQUENCY LEGION GXI NEUROTHERM, INC NT1100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR