BEUDAMED
    FDA Adverse Event Summary report: N

    NEUROTHERM DISPOSABLE GROUNDING PAD

    MDR report key: 3760714 · Received April 9, 2014

    Report

    Report Number
    1226344-2014-00001
    Date Received
    April 9, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    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 GROUNDING PAD UNDERWENT VISUAL, PERFORMANCE, AND MECHANICAL/PHYSICAL TESTING UPON RETURN ((B)(6) 2014) AND NO ABNORMALITIES WERE FOUND. CUSTOMER STATES THE INCIDENT MAY HAVE BEEN A RESULT OF IMPROPER PLACEMENT OF PAD. NO PICTURES OF THE BURN AREA OR ANY IMPEDANCE INFORMATION WERE AVAILABLE FOR REVIEW. NO PT TREATMENT WAS NEEDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, DOCTOR PERFORMED A 3 LEVEL RF WITH NT2000 UNIT S/N (B)(4). CANNULA IN USE SL-C1010-18 S/N (B)(4). PAD PLACED ON THE RIGHT FLANK OF PT. DOCTOR HAD JUST BEGUN FIRST LESIONING, WHEN AT APPROX 60 DEGREES CELSIUS THE PT COMPLAINED THAT IT HURT. PROCEDURE IMMEDIATELY HALTED AND PADS REMOVED. PT HAS TWO SUNBURN-TYPE BURNS. FIRST IN APPROX 1.25 INCHES BY 1.5 INCHES WITH 2 BALL POINT PEN MARK BUBBLES. SECOND IS ROUGHLY 2 INCHES BY 3.25 INCHES WITH 3 BALL POINT PEN MARK BUBBLES. ICE WAS IMMEDIATELY APPLIED TO THE AREAS AND DOCTOR ADVISED PT TO APPLY TOPICAL CREAM. UPON DISCHARGE OF PT, PT WAS PAIN FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213290 NEUROTHERM DISPOSABLE GROUNDING PAD DISPOSABLE GROUNDING PAD GXD NEUROTHERM, INC. RF-DGP-S 20130920

    Patients

    Seq Age Sex Outcome Treatment
    1 Other