BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTHERM DISPOSABLE GROUNDING PAD

    MDR report key: 4585077 · Received March 5, 2015

    Report

    Report Number
    3002953813-2015-00002
    Event Type
    Injury
    Date Received
    March 5, 2015
    Date of Event
    February 3, 2015
    Report Date
    February 3, 2015
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO A PHOTOGRAPHIC REVIEW OF THE GROUNDING PAD, WHICH SHOWED NO SIGNS OF DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE MODEL AND SERIAL OR LOT NUMBER OF THE DEVICE WAS UNAVAILABLE. THE GENERATOR WAS RETURNED AND INVESTIGATED. THE GENERATOR WAS RETURNED AND INVESTIGATED. THE GENERATOR USED IN THE PROCEDURE PASSED ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PATIENT BURN COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A RADIOFREQUENCY ABLATION PROCEDURE USING A NEUROTHERM GROUNDING PAD, A PATIENT BURN OCCURRED. THE NEUROTHERM GROUNDING PAD WAS APPLIED TO THE RIGHT POSTERIOR THIGH ABOVE THE KNEE. IT WAS NOTED THE PAD WAS NOT APPLIED TO AN AREA WITH HAIR OR LOTION PRESENT. TWO SMALL BLISTERS WERE OBSERVED AT THE SITE OF THE PAD AFTER THE PROCEDURE. THE PATIENT WAS TREATED WITH SILVADENE CREAM AND DISCHARGED. THE BURN WAS CLEAN AND DRY UPON FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152743 NEUROTHERM DISPOSABLE GROUNDING PAD DISPOSABLE GROUNDING PAD GXD NEUROTHERM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other