BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUROTHERM RF DISPOSABLE GROUNDING PAD

    MDR report key: 2933208 · Received January 10, 2013

    Report

    Report Number
    1226344-2013-00008
    Event Type
    Other
    Date Received
    January 10, 2013
    Date of Event
    August 30, 2011
    Report Date
    January 8, 2013
    Manufacturer
    NEUROTHERM
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: AS A RESULT OF CORRECTIVE ACTION (B)(4), POTENTIAL ADVERSE EVENTS ARE BEING REEVALUATED BASED ON AN INTERPRETATION CHANGE FOR THE REPORTING REQUIREMENTS FOR BURNS; THEREFORE, THIS MDR EXCEEDS THE 30 DAY REPORTING REQUIREMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A NEUROTHERM EMPLOYEE RECEIVED A CALL FROM THE FACILITY REPORTING A PT BURN. PT WAS AWAKE BUT HAD SOME SEDATION AND FELT BURNING. DOCTOR STOPPED THE PROCEDURE, REMOVED THE PAD, AND SAW A RED AREA. A SECOND PAD WAS PICKED UP FROM A DIFFERENT FACILITY AND THE PROCEDURE WAS COMPLETED. THE RED AREA BUBBLED UP AND WAS ABOUT 1 CM IN DIAMETER ACCORDING TO THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14971 NEUROTHERM RF DISPOSABLE GROUNDING PAD RF DISPOSABLE GROUNDING PAD GXD NEUROTHERM RF-DGP-L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other