BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TEMP

    MDR report key: 8944299 · Received August 29, 2019

    Report

    Report Number
    1314800-2019-00041
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    May 31, 2019
    Report Date
    August 29, 2019
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    IME
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED USING THE HOT/COLD PACK AND RECEIVED TWO BURNS ON BOTH SIDES OF HER LOWER BACK AFTER USING THE COLD PACK FOR AN EXTENDED PERIOD OF TIME. SHE REPORTED THAT SHE WAS NUMB FROM THE COLD SO SHE DID NOT FEEL ANY PAIN AT THE TIME. BUT SHE SOUGHT MEDICAL ATTENTION FOR THIS INCIDENT ON THE FOLLOWING DAY, AND ALSO HAD FOLLOW UP APPOINTMENTS WITH A DERMATOLOGIST. THE INSTRUCTIONS FOR PROPER USE STATES, "WARNING: FOLLOW INSTRUCTIONS CAREFULLY. MISUSE CAN CAUSE SEVERE BURNS. DO NOT APPLY THE INNER PACK DIRECTLY TO THE SKIN. ALWAYS USE THE CLOTH COVER". KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737842 SMART TEMP REUSABLE HOT/COLD PACK IME KAZ USA, INC., A HELEN OF TROY COMPANY HC1302 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R