BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 1082657 · Received July 21, 2008

    Report

    Report Number
    1811605-2008-00105
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    July 1, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 1/2" HOLE IN ONE SURFACE, ALTHOUGH THERE WAS NO EVIDENCE OF AN ACTUAL BURN. THE CONDITION OF THE UNIT SUGGESTED THAT THE UNIT HAD BEEN FOLDED DURING USE, WHICH HAD INSULATED AND INTENSIFIED THE HEAT LEVEL. THERE WAS ALSO EVIDENCE OF COMPRESSING AND DAMAGE TO INTERNAL COMPONENTS. WE CONCLUDED THAT THERE WAS NO ACTUAL DEFECT FOUND AND 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