BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2931383 · Received January 21, 2013

    Report

    Report Number
    1314800-2013-00004
    Event Type
    Other
    Date Received
    January 21, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING SECOND DEGREE BURNS FROM THE HEATING PAD. SHE STATES THE BURNS OCCURRED THREE WEEKS AGO. THE HEATING PAD WAS WRAPPED IN TWO TOWELS AND IT SLID DOWN HER BACK. THE INSTRUCTIONS FOR USE WARN AGAINST WRAPPING THE HEATING PAD IN ANYTHING OTHER THAN THE COVER PROVIDED AS IT COULD LEAD TO OVERHEATING. THE CONSUMER HAS BEEN TREATED MEDICALLY AND IS ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28721 SOFTHEAT HEATING PAD IRT KAZ INC HP980 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other