BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 1082655 · Received July 21, 2008

    Report

    Report Number
    1811605-2008-00107
    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
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE FABRIC FOUNDATION OF THE UNIT WAS BURNED BY AN INTERNAL COMPONENT. INSPECTION OF THE UNIT REVEALED A TERMINAL HAD BROKEN AT THE LEAD WIRE. THE CONDITION OF THE UNIT SUGGESTED THAT THE UNIT HAD BEEN SEVERELY COMPRESSED, WITH DAMAGE TO MANY INTERNAL COMPONENTS. WE CONCLUDED THAT THIS REPORT WAS ATTRIBUTABLE TO MISUSE ON THE PART OF THE CONSUMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1