BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTTEMP

    MDR report key: 5276830 · Received November 25, 2015

    Report

    Report Number
    1314800-2015-00077
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    October 29, 2015
    Report Date
    November 25, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    IME
    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

    THE CONSUMER REPORTED USING THE HOT/COLD PACK AS A COLD PACK AND RECEIVED TWO BLISTERS AFTER USING THE PRODUCT ON HER KNEE. SHE STATED THAT SHE WAS GOING TO BE SEEKING MEDICAL ATTENTION FOR THIS INCIDENT. 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
    782254 SMARTTEMP HOT/COLD PACK IME KAZ USA, INC. HC1302 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention