BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 1203248 · Received October 9, 2008

    Report

    Report Number
    1811605-2008-00131
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 22, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT CO.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT EMITTED SMOKE. VISUAL EXAMINATION AND ELECTRICAL TESTING OF THE UNIT REVEALED NO DEFECT OR EVIDENCE OF A PRIOR DEFECT THAT HAD RESULTED IN EXCESSIVE HEAT OR SMOKE. THE UNIT PERFORMED WITHIN EXPECTED TOLERANCES. WE WERE UNABLE TO DETECT ANY DEFECT IN THIS UNIT.

    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 CO. 155

    Patients

    Seq Age Sex Outcome Treatment
    1