BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 4748715 · Received May 1, 2015

    Report

    Report Number
    1314800-2015-00035
    Event Type
    Other
    Date Received
    May 1, 2015
    Date of Event
    July 1, 2014
    Report Date
    May 1, 2015
    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

    A CONSUMER CALLED TO INFORM US THAT SHE RECEIVED 3RD DEGREE BURNS ON HER LEGS AND GROIN AREA WHILE USING A HEATING PAD. MEDICAL ATTENTION WAS REQUIRED FOR HER INJURIES. THE CONSUMER STATED THAT SHE WAS USING THE HEATING PAD IN BED AND SHE HAD FALLEN ASLEEP. SHE ALSO STATES THAT THE AUTOMATIC SHUT-OFF FEATURE DID NOT ENGAGE, AND THAT THE HEATING PAD WAS STILL ON WHEN SHE WOKE UP 12 HOURS LATER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289291 SOFTHEAT HEATING PAD IRT KAZ, INC. HP-212 33814

    Patients

    Seq Age Sex Outcome Treatment
    1 Other