BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 1082654 · Received July 21, 2008

    Report

    Report Number
    1811605-2008-00108
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 14, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SWITCH FAILED TO SHUT OFF AS DESIGNED AT THE END OF THE 20-MINUTE CYCLE. EXAMINATION AND TESTING OF THE UNIT REVEALED NO SPECIFIC DEFECT, BUT WE WERE ABLE TO DETERMINE THAT THE TIMER WOULD OCCASIONALLY MALFUNCTION. WE ATTRIBUTED THIS REPORT TO AN UNUSUAL PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOPHORE ARTHRITIS PAD ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 155

    Patients

    Seq Age Sex Outcome Treatment
    1