BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 2043074 · Received March 15, 2011

    Report

    Report Number
    1811605-2011-00016
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BATTLE CREEK EQUIPMENT CO.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SWITCH EMITTED SPARKS. OUR INVESTIGATION REVEALED THAT THE SWITCH HOUSING APPEARED SEVERELY DAMAGED AND HAD EVIDENCE OF A SPARK. IT APPEARS THAT THE SWITCH HOUSING WAS CRUSHED AND THE USER ATTEMPTED TO REPAIR BEFORE THE UNIT MALFUNCTIONED. WE CONCLUDED THAT THIS REPORT WAS ATTRIBUTED TO MISUSE AND UNAUTHORIZED MODIFICATION OF THE SWITCH ON THE PART OF THE CONSUMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SWITCH EMITTED SPARKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1