BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 3820077 · Received May 12, 2014

    Report

    Report Number
    1314800-2014-00050
    Event Type
    Other
    Date Received
    May 12, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 12, 2014
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER CALLED TO REPORT THAT HIS HEATING PAD HAD CAUGHT ON FIRE, WHICH RESULTED IN MINOR BURNS ON THE PATIENT'S STOMACH, AS WELL AS DAMAGE TO HIS BLANKET AND BED. MEDICAL ATTENTION WAS NOT REQUIRED FOR HIS INJURY. BURNS OF THIS NATURE ARE MOST LIKELY CAUSED BY THE CONSUMER LAYING OR LEANING AGAINST THE PAD 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 CONSUMER 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. KAZ HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284838 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP950 14110

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other