BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROTHERM DISPOSABLE GROUNDING PAD

    MDR report key: 4099338 · Received September 5, 2014

    Report

    Report Number
    3002953813-2014-00009
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GROUNDING PAD USED DURING THE PROCEDURE WAS NOT AVAILABLE FROM THE CUSTOMER FOR EVAL. HOWEVER, A PHOTO WAS PROVIDED AND SHOWED A GREAT AMOUNT OF HAIR ADHERED TO THE PAD. THE GENERATOR USED WAS SENT BACK FOR EVAL TO ENSURE NO ABNORMALITIES WERE PRESENT. THE GENERATOR PASSED ALL DATA INSPECTION REPORTS. NEUROTHERM REPRESENTATIVES SPOKE WITH THE NURSE PRESENT DURING THE PROCEDURE. SHE EXPLANTED THAT THE PT COMPLAINED ABOUT A BURNING SENSATION AND WHEN SHE CHECKED SHE NOTICED THE PAD WAS KINKED IN THE MIDDLE ON THE PT'S BACK. TISSUE AND HAIR WAS REMOVED WITH PAD. IT WAS SUGGESTED AS A PREVENTIVE MEASURE TO SHAVE THE PT AND FOLLOW THE INSTRUCTIONS ON THE IFU. (B)(4).

    Description of Event or Problem · 1

    A PT RECEIVED A BURN FROM A GROUNDING PAD DURING A CERVICAL PROCEDURE ON THE RIGHT SIDE OF THE BACK. BURN WAS 2ND DEGREE, APPROXIMATELY 2-3 CM. PT WAS TREATED WITH SILVADENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546321 NEUROTHERM DISPOSABLE GROUNDING PAD DISPOSABLE GROUNDING PAD GXD NEUROTHERM, INC. FR-DGP-S 20140221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other