BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTHEAT

    MDR report key: 5147855 · Received October 7, 2015

    Report

    Report Number
    1314800-2015-00070
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 7, 2015
    Report Date
    October 7, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: THE SAMPLE WAS PLUGGED INTO A 120V SUPPLY AND OPERATED ON ITS HIGHEST HEAT SETTING. ONCE THE TEMPERATURE ON THE PAD STABILIZED A THERMAL IMAGE WAS TAKEN AND THE MAXIMUM TEMPERATURE REACHED WAS RECORDED. THE MAXIMUM TEMPERATURE REACHED ON THE HEATING PAD AS SEEN BY THE THERMAL CAMERA WAS 59. 9 DEGREES C. THIS WAS IN THE AREA OF THE SHARP FOLDS. SIX THERMOCOUPLES, SOLDERED TO 1/2" X 1/4" X 1MM COPPER STRIPS WITH ROUNDED CORNERS, WERE TAPED TO THE HEATING PAD IN THE SIX HOTTEST SPOTS SEEN BY THE THERMAL CAMERA. THE UL130 FULL BLANKET TEST WAS PERFORMED ON THE PAD UNTIL THE AUTO-SHUTOFF TURNED THE SAMPLE OFF. THE MAXIMUM TEMPERATURE REACHED WAS RECORDED. THE MAX TEMPERATURE REACHED WAS 111.6 DEGREES C. THESE ARE FAILING RESULTS DUE TO THE DAMAGE TO THE PAD. PER THE CONSUMER'S STATEMENT THE PAD WAS LAID ON WHICH WAS IDENTIFIED BY THE LAB AS THE CAUSE OF THE WRINKLED AREAS. THE PRINTED INSTRUCTIONS ON THE PAD STATE NOT TO LAY OR LEAN AGAINST THE HEATING PAD. THE AUTO-SHUTOFF CORRECTLY TURNED THE SAMPLE OFF IN APPROXIMATELY AN HOUR.

    Description of Event or Problem · 1

    A CONSUMER CALLED TO INFORM US THAT HE HAD ALLEGEDLY RECEIVED 2ND DEGREE BURNS ON HIS BACK WHILE USING A HEATING PAD. MEDICAL ATTENTION WAS SOUGHT FOR HIS INJURIES. THE CONSUMER STATED THAT HE WAS SLEEPING ON TOP OF THE HEATING PAD WHEN THE INCIDENT OCCURRED. HE ALSO ALLEGES THAT THE AUTOMATIC SHUT OFF FEATURE DID FUNCTION PROPERLY WHEN THE INCIDENT OCCURRED. THE INSTRUCTIONS FOR PROPER USE CLEARLY STATE NOT TO USE THIS PRODUCT WHILE SLEEPING. IT ALSO STATES, "THIS HEATING PAD IS INTENDED FOR USE ON TOP OF YOUR BODY. DO NOT SIT OR LIE ON TOP OF THE HEATING PAD. NEVER PLACE PAD BETWEEN YOURSELF AND CHAIR, SOFA, BED OR PILLOW." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR LAB ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664475 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP-750 12413

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R| S