BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 3173140 · Received June 5, 2013

    Report

    Report Number
    1811605-2013-00077
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BATTLE CREEK EQUIPMENT CO.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INSPECTION FOUND A SMALL CUT IN THE CORD NEAR THE SWITCH THAT COULD HAVE EXPOSED THE USER TO BARE WIRE. PAD WAS BUNCHED UP, LEADS WERE OUT OF PLACE AND 3 THERMOSTATS WERE BENT IN HALF. CORD BREAKAGE USUALLY OCCURS WHEN THE CORD IS REPEATEDLY OVER BENT NEAR THE SWITCH. WE HAVE INITIATED A CAPA PROJECT ((B)(4)) TO REDUCE THE OCCURRENCE OF THIS ISSUE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PAD SPARKED AND STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249617 THERMOPHORE AUTOMATIC MOIST HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT CO. 095

    Patients

    Seq Age Sex Outcome Treatment
    1