BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2418289 · Received January 3, 2012

    Report

    Report Number
    1314800-2011-00057
    Event Type
    Other
    Date Received
    January 3, 2012
    Date of Event
    November 28, 2011
    Report Date
    December 30, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING A BURN ON HER LEFT THIGH FROM USING THE HEATING PAD. SHE WAS LAYING ON THE HEATING PAD AT THE TIME OF THE EVENT. THE OWNERS MANUAL FOR THIS UNIT CLEARLY STATES TO NOT LAY OR LEAN AGAINST THE HEATING PAD AS IT COULD RESULT IN A BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ, INC. HP710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other