BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROTHERM DISPOSABLE GROUNDING PAD

    MDR report key: 3915770 · Received June 12, 2014

    Report

    Report Number
    3002953813-2014-00004
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GROUNDING PAD USED DURING THE PROCEDURE WAS NOT AVAILABLE FROM THE CUSTOMER FOR EVAL. THE GENERATOR USED WAS SENT BACK FOR EVAL TO ENSURE NO ABNORMALITIES WERE PRESENT. THE GENERATOR PASSED ALL DATA INSPECTION REPORTS CONDUCTED BY TWO SEPARATE TECHS; (B)(4).

    Description of Event or Problem · 1

    A PT RECEIVED A FIRST DEGREE BURN FROM A GROUNDING PAD. REDNESS DID NOT OCCUR UNTIL THE DAY AFTER THE PROCEDURE. THE LINE BLISTERED SLIGHTLY, THE BLISTER FELL AND REVEALED MINIMAL REDNESS WITH NO DISCHARGE OR SIGN OF INFECTION. PT WAS TREATED WITH NEOSPORIN DRESSING. AS OF (B)(6) 2014, THE PT WAS DOING FINE AND THE SKIN WAS HEALING WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346549 NEUROTHERM DISPOSABLE GROUNDING PAD DISPOSABLE GROUNDING PAD GXD NEUROTHERM, INC. RF-DGP-S 20131220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other