BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF DISPOSABLE GROUNDING PAD

    MDR report key: 7068575 · Received November 29, 2017

    Report

    Report Number
    3002953813-2017-00044
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    November 6, 2017
    Report Date
    January 24, 2018
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K111576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF A PATIENT BURN WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED BURN COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    A PATIENT BURN OCCURRED AT THE GROUNDING PAD SITE DURING THE PROCEDURE. THERE WAS NO SKIN PREP PERFORMED AND THE PATIENT WAS HAIRY. BLISTERING OF THE SKIN WAS NOTED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848170 RF DISPOSABLE GROUNDING PAD DISPOSABLE GROUNDING PAD GXD NEUROTHERM, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other