BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 1790672 · Received August 3, 2010

    Report

    Report Number
    1314800-2008-00015
    Event Type
    Other
    Date Received
    August 3, 2010
    Date of Event
    January 9, 2008
    Report Date
    July 29, 2010
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED USING THE HEATING PAD FOR HIS MOTHER WHO HAS DIABETES AND HAS SUFFERED A STOKE. HE USES THE HEATING PAD ON THE PARALYZED SIDE OF HER BODY WHILE SHE SLEEPS. DURING THE NIGHT HIS MOTHER RECEIVED BURNS TO HER LEG AND BUTTOCKS THAT REQUIRED MEDICAL ATTENTION. THE INSTRUCTIONS FOR USE CLEARLY STATE THE HEATING PAD IS NOT TO BE USED WHILE SLEEPING OR BY ANY PERSON WITH DIABETES OR OTHER CONDITIONS WHICH CAUSE NUMBNESS OR PARALYSIS.

    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 UNK Other