BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF DISPOSABLE GROUNDING PAD

    MDR report key: 7046351 · Received November 20, 2017

    Report

    Report Number
    3002953813-2017-00041
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    October 31, 2017
    Report Date
    December 18, 2017
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K111576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BURN COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED BURN MAY HAVE BEEN PROCEDURE RELATED.

    Description of Event or Problem · 1

    DURING A RADIOFREQUENCY ABLATION PROCEDURE, A PATIENT BURN OCCURRED AT THE GROUNDING PAD SITE. THE SKIN WAS NOT PREPPED AND THE GROUNDING PAD WAS PLACED ON THE THIGH WITH HAIR PRESENT. UPON REMOVAL OF THE GROUNDING PAD THERE WAS SKIN REMOVED FROM THE SITE. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823597 RF DISPOSABLE GROUNDING PAD DISPOSABLE GROUNDING PAD GXD NEUROTHERM, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other