BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 2220175 · Received August 15, 2011

    Report

    Report Number
    1811605-2011-00095
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED SPARKS FROM THE SWITCH WHEN UNPLUGGING IT FROM THE OUTLET. UPON EXAMINATION, THE CORD APPEARS TO HAVE BEEN CUT BY SOME UNUSUAL EVENT PRIOR TO THE FAILURE. WE ARE UNABLE TO DETERMINE WHETHER THE FAILURE WOULD HAVE OCCURRED HAD THE CORD NOT BEEN DAMAGED. THE CORD APPEARS TO HAVE BEEN CAUGHT IN SOMETHING AND CUT BEFORE THE EVENT OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORD EMITTED SPARKS NEAR THE SWITCH WHEN THE USER UNPLUGGED THE UNIT FROM THE OUTLET.

    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