BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 1963255 · Received January 10, 2011

    Report

    Report Number
    1314800-2010-00055
    Event Type
    Other
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 29, 2010
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING THIRD DEGREE BURNS ON HER STOMACH. SHE WENT TO HER DOCTOR FOR BURN CREAM TO TREAT THE INJURY. A BURN OF THIS NATURE IS USUALLY THE RESULT OF LAYING OR LEANING AGAINST THE HEATING PAD WHICH IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ INC HP218 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other