BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 2043035 · Received March 15, 2011

    Report

    Report Number
    1811605-2011-00028
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    December 4, 2010
    Report Date
    March 3, 2011
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE UNIT BURNED. BECAUSE OF COLLATERAL DAMAGE TO THE CUSTOMER'S HOME, THEIR INSURANCE COMPANY TOOK POSSESSION OF THE UNIT AND CONTACTED US. AT THIS TIME, WE HAVE BEEN UNABLE TO OBTAIN FURTHER DETAILS OF THE INCIDENT. WE WILL FILE A FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT BURNED.

    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