BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2931382 · Received January 21, 2013

    Report

    Report Number
    1314800-2013-00005
    Event Type
    Other
    Date Received
    January 21, 2013
    Date of Event
    January 14, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING TWO BURNS FROM USE OF THE HEATING PAD. SHE REPORTS HAVING A PERMANENT SCAR ON HER STOMACH AS WELL AS A BURN TO HER LEFT ARM. BURNS OF THIS NATURE CAN BE CAUSED BY THE CONSUMER 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
    28608 SOFTHEAT HEATING PAD IRT KAZ INC HP980 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other