BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 3131479 · Received February 25, 2013

    Report

    Report Number
    1811605-2013-00029
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 STOPPED WORKING. OUR INSPECTION FOUND A SMALL CUT IN THE CORD NEAR THE SWITCH THAT COULD HAVE EXPOSED THE USER TO BARE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81145 THERMOPHORE AUTOMATIC MOIST HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 055

    Patients

    Seq Age Sex Outcome Treatment
    1