BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2354906 · Received November 21, 2011

    Report

    Report Number
    1314800-2011-00047
    Event Type
    Other
    Date Received
    November 21, 2011
    Date of Event
    November 7, 2011
    Report Date
    November 7, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED HIS WIFE RECEIVED SEVERE BURNS FROM THE HEATING PAD. THE PATIENT WAS LAYING ON THE HEATING PAD AT THE TIME OF THE EVENT. SHE ALSO RECENTLY HAD SPINAL CORD SURGERY AND IS UNABLE TO MOVE. THE CONSUMER REPORTED THE BURNS WERE SEVERE ENOUGH TO CAUSE BLEEDING OF THE INCISION SITE. THE OWNERS MANUAL AND WARNINGS ON THE DEVICE PROHIBIT USE BY CONSUMERS WITH MOBILITY ISSUES AS WELL AS LAYING OR SLEEPING ON THE HEATING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT * IRT KAZ, INC. HP215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other