BEUDAMED
    FDA Adverse Event Other Summary report: N

    IDEAL

    MDR report key: 451627 · Received March 31, 2003

    Report

    Report Number
    MW1028015
    Event Type
    Other
    Date Received
    March 31, 2003
    Date of Event
    March 10, 2003
    Report Date
    March 18, 2003
    Manufacturer
    IDEAL MEDICAL PRODUCTS
    Product Code
    LHC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING ULTRASOUND TO NECK. WHEN GEL WAS APPLIED TO SCAN AREA, THE PT JUMPED UP STATING IT BURNED THEIR NECK. GEL WAS WIPED OFF AND EXAM COMPLETED USING COOL GEL. THE WARMER USED TO WARM THE GEL WAS TAKEN OUT OF SERVICE. THE THERMOSTAT STOP GUARD ON THE UNIT WAS BROKEN ALLOWING THE DIAL TO BE TURNED UP EXCEEDING TEMPERATURE SETTING MAXIMUM. PT HAD MEDICAL EXAM. TREATED FOR FIRST DEGREE BURN TO NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDEAL GEL WARMER LHC IDEAL MEDICAL PRODUCTS GW 208 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other