BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SIMPLICITY ELECTRODE

    MDR report key: 6328352 · Received February 14, 2017

    Report

    Report Number
    3002953813-2017-00001
    Event Type
    Injury
    Date Received
    February 14, 2017
    Date of Event
    January 12, 2017
    Report Date
    January 20, 2017
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED BURN COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A SIMPLICITY PROCEDURE, A PATIENT BURN OCCURRED. UPON COMPLETION OF THE PROCEDURE AND REMOVAL OF THE SPINAL NEEDLES, A SMALL 1-2MM BURN WAS NOTED ON THE UPPER RIGHT BUTTOCK WHICH DEVELOPED A SMALL BLANCHED AREA AROUND IT. APPROXIMATELY TWO HOURS POST PROCEDURE, THE LESION WAS 10MM IN DIAMETER. A DERMATOLOGIST WAS CONSULTED AND THE PATIENT WAS TREATED WITH BETNOVATE CREAM BD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112745 DISPOSABLE SIMPLICITY ELECTRODE PROBE, RADIOFREQUENCY LESION GXD NEUROTHERM, INC RFDE-SI 9801759

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR