BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 1001271 · Received February 18, 2008

    Report

    Report Number
    1811605-2008-00021
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 11, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED AN INTERNAL ELECTRICAL COMPONENT SPARKED AND/OR BURNED THE FABRIC FOUNDATION OF THE UNIT. VISUAL INSPECTION OF THE UNIT REVEALED A BROKEN THERMOSTAT, DAMAGED BY MISUSE ON THE PART OF THE CONSUMER, WHICH HAD BRIEFLY ALLOWED ELECTRICITY TO COME INTO CONTACT WITH THE FABRIC FOUNDATION, RESULTING IN A 1/4" BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOPHORE AUTOMATIC MOIST HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 055

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK