BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 1001265 · Received February 18, 2008

    Report

    Report Number
    1811605-2008-00024
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 5, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SWITCH EMITTED SPARKS. VISUAL INSPECTION OF THE SWITCH COMPONENTS REVEALED THAT THE ELECTRICAL CORD HAD BEEN SUBJECTED TO A GREAT DEAL OF STRESS, PULLING THE WIRE CONNECTIONS APART AND ALLOWING THE WIRE TO EMIT SPARKS. 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 155

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK