BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOFTHEAT

    MDR report key: 3186930 · Received June 19, 2013

    Report

    Report Number
    1314800-2013-00027
    Event Type
    Death
    Date Received
    June 19, 2013
    Date of Event
    October 5, 2012
    Report Date
    May 21, 2013
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BASED ON INFORMATION OBTAINED FROM (B)(6). THE REPORT STATED THAT (B)(6) WOMAN DIED 4 DAYS AFTER BEING INJURED IN A FIRE AT HER HOUSE ON (B)(6) 2012. SHE HAD DISCOVERED THE FIRE IN A PILLOW ON HER BED. SHE PICKED UP THE PILLOW AND CARRIED IT TO THE BATHROOM IN AN ATTEMPT TO PUT OUT THE FIRE, HANDLING THE PILLOW CAUSED THE FIRE TO SPREAD TO HER BODY AND CLOTHING, AND THEN IGNITED COMBUSTIBLES IN THE BATHROOM. AS A RESULT, SHE WAS BURNED OVER 45% OF HER BODY. SHE ABANDONED THE ATTEMPT TO EXTINGUISH THE FIRE AN RAN OUTSIDE THE HOUSE. NEIGHBORS DISCOVERED HER AND CALL 911. WHEN FIRE INVESTIGATORS INTERVIEWED THE WOMAN, SHE STATED THAT SHE HAD BEEN COOKING IN THE KITCHEN AND RETURNED TO HER BEDROOM TO FIND HER PILLOW ON FIRE. THE FIRE DEPARTMENT CONCLUDED THAT THE FIRE WAS ACCIDENTAL IN NATURE. THEY DETERMINED THE FIRE WAS CAUSED BY AN OVERHEATED HEATING PAD THAT WAS ON TOP OF A PILLOW AND BEDDING, WITH ANOTHER PILLOW ON TOP OF THE HEADING PAD. THE FIRE DEPARTMENT ALSO FOUND THAT THE HEATING PAD HAD BEEN PLUGGED INTO SEVERAL MULTI-PLUG ADAPTERS WITH MANY OTHER ITEMS. THE FIRE MARSHALL INCIDENT REPORT STATED THAT THE IGNITION FACTOR AND FACTOR CONTRIBUTING TO IGNITION WERE "HEAT SOURCE TOO CLOSE TO COMBUSTIBLES"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278488 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP980 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death