BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 1250727 · Received December 1, 2008

    Report

    Report Number
    1811605-2008-00147
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 14, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE FABRIC FOUNDATION OF THE UNIT WAS BURNED. INSPECTION OF THE UNIT REVEALED SIGNIFICANT DAMAGE TO THE FABRIC FOUNDATION AND COVER OF THE HEATING UNIT CAUSED BY EXCESSIVE LEVELS OF HEAT, HOWEVER, THERE WAS NO EVIDENCE OF AN ACTUAL BURN. THE CONDITION OF THE UNIT SUGGESTED THAT THE UNIT HAD BEEN FOLDED DURING USE, COMPRESSING AND BREAKING THE COMPONENT. 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 156

    Patients

    Seq Age Sex Outcome Treatment
    1