BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 4728251 · Received April 21, 2015

    Report

    Report Number
    1314800-2015-00018
    Event Type
    Other
    Date Received
    April 21, 2015
    Date of Event
    March 19, 2015
    Report Date
    April 2, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAXIMUM TEMPERATURE RECORDED WITH THE THERMAL CAMERA WAS 69.2°C. THIS IS IN THE AREA OF THE SHARPS FOLDS AND DISCOLORATION. USING THE THERMAL CAMERA THE 6 HOTTEST POINTS ON THE HEATING PAD WERE CHOSEN. SIX THERMOCOUPLES SOLDERED TO 1/2"X1/4"X1MM THICK COPPER STRIPS WITH ROUNDED CORNERS WERE TAPED TO THE HEATING PAD ON THE 6 HOTTEST POINTS CHOSEN. THESE SPOTS WERE IN THE AREA OF THE SHARP FOLDS. THE UL130 FULL BLANKET TEST WAS PERFORMED ON THE SAMPLE UNTIL THE AUTO-SHUTOFF SHUT THE UNIT OFF. TEMPERATURES WERE MONITORED THROUGHOUT THE TEST AND THE MAXIMUM TEMPERATURE REACHED WAS RECORDED. THE MAXIMUM TEMPERATURE REACHED DURING THE UL130 FULL BLANKET TEST WAS 115°C AT AN AMBIENT TEMPERATURE OF 24.0°C. THESE ARE FAILING RESULTS DUE TO THE DAMAGE TO THE PAD. THE MOST LIKELY CAUSE OF THE FAILURE IS FROM THE PRODUCT BEING SAT ON OR LAID ON . THE CONSUMER ADMITTED THAT SHE WAS LAYING ON THE HEATING PAD, AND THE INSTRUCTIONS CLEARLY STATE NOT TO DO SO.

    Description of Event or Problem · 1

    A CONSUMER CALLED AND STATED THAT SHE WAS ALLEGEDLY BURNED WHILE USING A HEATING PAD. THIS INCIDENT RESULTED IN A QUARTER SIZED SECOND DEGREE BURN ON HER WRIST, WHICH REQUIRED MEDICAL TREATMENT. THE PATIENT ALSO STATED THAT THIS INCIDENT OCCURRED WHILE SHE WAS SLEEPING WITH THE HEATING PAD PLACED BETWEEN HERSELF AND A PILLOW, WHICH IS CONTRARY TO PROPER USE OF INSTRUCTION. THE PRODUCT HAS A CLEAR WARNING THAT STATES THE PRODUCT IS INTENDED FOR USE ON TOP OF THE BODY, AND CONSUMERS SHOULD NOT SIT AGAINST OR LAY ON TOP OF THE HEATING PAD. THE INSTRUCTION ALSO HAVE A WARNING TO NEVER PLACE THE PAD BETWEEN YOURSELF AND A CHAIR, SOFA, BED, OR PILLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265343 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP-215 30213

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other