BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 4620562 · Received March 16, 2015

    Report

    Report Number
    1314800-2015-00009
    Event Type
    Other
    Date Received
    March 16, 2015
    Report Date
    March 11, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TEST DATE: (B)(4) 2015; TEST LAB OBSERVATIONS: THE SAMPLE WAS REMOVED FROM THE BOX AND INSPECTED. THE PAD IS SLIGHTLY WRINKLED WITH A SHARP FOLD IN IT. THERE WERE NO OTHER DEFECTS NOTED. ROOT CAUSE ANALYSIS: THE SAMPLE WAS PLUGGED INTO A 120V SUPPLY AND TURNED ON TO ITS HIGHEST HEAT SETTING. THE SAMPLE WAS ALLOWED TO OPERATE UNTIL THE TEMPERATURE ON THE PAD STABILIZED. A THERMAL IMAGE WAS TAKEN USING THE THERMAL CAMERA AND THE MAXIMUM TEMPERATURE REACHED WAS RECORDED. THE MAXIMUM TEMPERATURE REACHED WAS 51.2 DEGREE C. THIS WAS IN THE AREA OF THE SHARP FOLD. USING THE THERMAL IMAGE THE SIX HOTTEST SPOTS WERE CHOSEN FOR THE UL130 FULL BLANKET TEST. THIS WAS IN THE AREA OF THE SHARP FOLD. THE TEST WAS PERFORMED UNTIL THE AUTO SHUTOFF TURNED AND SAMPLE OFF. THE MAXIMUM TEMPERATURE REACHED WAS RECORDED. THE MAXIMUM TEMPERATURE REACHED DURING THE UL130 FULL BLANKET TEST WAS 64.2 DEGREE C AT AN AMBIENT TEMPERATURE OF 24 DEGREE C. THESE ARE PASSING RESULTS. THIS CUSTOMER ADMITTED TO LAYING ON THE HEATING PAD. THE DIRECTIONS PRINTED ON THE PAD CLEARLY STATE NOT TO DO SO.

    Description of Event or Problem · 1

    A CONSUMER CALLED AND STATED THAT HER SISTER WAS ALLEGEDLY BURNED WHILE USING A HEATING PAD. THIS INCIDENT RESULTED IN THIRD DEGREE BURNS ON HER BACK, WHICH REQUIRED TREATMENT FROM A DOCTOR. THE PT ALSO STATED THAT THIS INCIDENT OCCURRED WHILE SHE HAD THE PAD BEHIND HER BACK WHILE LAYING ON A COUCH, WHICH IS CONTRARY TO PROPER USE 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 INSTRUCTIONS 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
    178198 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP950 1867

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other