BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE GROUNDING PAD W/OUT CABLE

    MDR report key: 5029446 · Received August 25, 2015

    Report

    Report Number
    3002953813-2015-00017
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    July 28, 2015
    Report Date
    July 29, 2015
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER PREVIOUSLY REPORTED WAS INCORRECT AND REMAINS UNKNOWN. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE RECEIVING INSPECTION RESULTS WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PATIENT BURN COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, BURNS ARE A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING A LEFT CERVICAL C2, C3, C4 ABLATION PROCEDURE, A PATIENT BURN OCCURRED. A NEUROTHERM GROUNDING PAD WAS PLACED ON THE RIGHT UPPER ARM. THE PATIENT WAS NEITHER HAIRY OR DIAPHORETIC AND NO LOTION WAS APPLIED. AN ARC AT THE GROUNDING PAD WAS NOTED NEAR THE END OF THE PROCEDURE AND IT WAS NOTED THERE WERE WRINKLES ON THE PAD. WHEN THE GROUNDING PAD WAS REMOVED, A 1X1.5" SECOND DEGREE BURN WAS NOTED ON THE ARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO IMMEDIATE TREATMENT OF THE BURN WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559942 DISPOSABLE GROUNDING PAD W/OUT CABLE PROBE, RADIOFREQUENCY LESION GXD NEUROTHERM, INC RF-DGP-L L764

    Patients

    Seq Age Sex Outcome Treatment
    1 Other