BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALTHSMART

    MDR report key: 11207444 · Received January 21, 2021

    Report

    Report Number
    1422443-2021-00001
    Event Type
    Injury
    Date Received
    January 21, 2021
    Date of Event
    January 3, 2021
    Report Date
    January 21, 2021
    Manufacturer
    CARDICARE COMPANY LTD
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTED UNIT. UNIT LOOKS TO HAVE BEEN USED EXCESSIVELY. HEATING PAD IS TORN WHERE THE ELECTRICAL CABLE COMES OUT AT THE TOP RIGHT CORNER. MIGHT BE DUE TO MISHANDLING OF PRODUCT. PULL AND/OR TUGGING OF UNIT. PLUGGED IN UNIT INTO OUTLET. UNIT SUCCESSFULLY POWERS ON. CYCLED THROUGH ALL HEAT LEVELS OF THE UNIT TO VERIFY ALL COLOR INDICATOR LAMPS WERE FULLY FUNCTIONAL. TURNED ON UNIT TO HIGH SETTING AT 9:10AM. VERIFIED UNIT WAS HEATING AND STILL POWERED ON EVERY 15 MINUTES UNTIL UNIT AUTOMATICALLY POWERED OFF AT 11:10AM. TURNED ON UNIT TO MEDIUM SETTING AT 11:30AM. VERIFIED UNIT WAS HEATING AND STILL POWERED ON EVERY 15 MINUTES UNTIL UNIT AUTOMATICALLY POWERED OFF AT 1:30PM. UNIT SEEMS TO BE FUNCTIONING NORMAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE END USER DOZED OFF WHILE USING THE HEATING PAD AND RECEIVED A BURNED ON HER BACK. THE END USER CONTACTED HER DOCTOR AND HAS BEEN APPLYING HYDROCORTISONE OINTMENT WITH PAIN RELIEVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER DOZED OFF WHILE USING THE HEATING PAD AND RECEIVED A BURNED ON HER BACK. THE END USER CONTACTED HER DOCTOR AND HAS BEEN APPLYING HYDROCORTISONE OINTMENT WITH PAINT RELEIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107722 HEALTHSMART HEATING PAD IRT CARDICARE COMPANY LTD 619-5133-1900 90241218

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other