BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMOPHORE DEEP-HEAT THERAPY

    MDR report key: 3803054 · Received May 6, 2014

    Report

    Report Number
    MW5035965
    Event Type
    Other
    Date Received
    May 6, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 22, 2014
    Manufacturer
    BATTLE CREEK EQUIPMENT
    Product Code
    IRT
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THIS HEATING PAD WHILE SITTING IN A CHAIR WITH THE PAD PLACED BETWEEN MY BACK AND THE CHAIR BACK. WHEN I PRESSED THE LEVER TO HEAT THE PAD, THE CORD SHORTED, BURNED AT THE SWITCH, SHOT OUT A YELLOW FLAME AND SEVERED THE CORD AT THE SWITCH. I CALLED THE COMPANY AND THEY SENT OUT A NEW PAD AS A REPLACEMENT. THE NEW PAD (SERIAL# (B)(4)) HAS A SINGLE THICK VS A DOUBLE THIN CORD THAT WAS ON THE OLD PAD. PER THE COMPANY'S REQUEST, I RETURNED THE ORIGINAL PAD TO THEM IN THE NEW PAD'S BOX ((B)(4)). THE COMPANY WAS VERY CO-OPERATIVE. IF THERE ARE OTHER PADS WITH THE DOUBLE WIRE THIN CORD AND SOMEONE IS IN BED OR CLOSE TO COMBUSTIBLE MATERIALS, THERE COULD BE A RISK OF A SERIOUS BURN AND POTENTIAL OF FIRE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271552 THERMOPHORE DEEP-HEAT THERAPY 055 STANDARD THERMOPHORE IRT BATTLE CREEK EQUIPMENT 055

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR