BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 4748717 · Received May 1, 2015

    Report

    Report Number
    1314800-2015-00038
    Event Type
    Other
    Date Received
    May 1, 2015
    Date of Event
    March 23, 2015
    Report Date
    May 1, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER CALLED TO INFORM US THAT HE HAD RECEIVED 3RD DEGREE BURNS ON HIS ANKLE AND HEEL WHILE USING A HEATING PAD. MED ATTENTION WAS REQUIRED FOR HIS INJURIES. THE CONSUMER STATED THAT HE WAS USING THE HEATING PAD ON HIS ANKLE AND THAT HE HAD FALLEN ASLEEP, AND THAT THE AUTOMATIC SHUT-OFF FEATURE DID NOT ENGAGE. THE INSTRUCTIONS FOR PROPER USE CLEARLY STATE THAT THIS PAD IS NOT TO BE USED ON OR BY AN INVALID, SLEEPING, OR UNCONSCIOUS PERSON. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR LAB ANALYSIS, BUT THE CONSUMER IS REFUSING TO DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289634 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP-215 32814

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other