BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTTEMP

    MDR report key: 4868614 · Received June 22, 2015

    Report

    Report Number
    1314800-2015-00050
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 22, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT HER DAUGHTER RECEIVED BURNS FORM A HOT/COLD GEL PACK. SHE STATED THAT HER DAUGHTER RECEIVED BURNS ON HER HAND, ARM, AND FOOT AS A RESULT OF THIS INCIDENT. THE PATIENT RECEIVED MEDICAL TREATMENT FOR HER INJURIES. THE CONSUMER STATED THAT SHE HEATED THE HOT/COLD GEL PACK IN HER 1450 WATT MICROWAVE FOR APPROXIMATELY 90-120 SECONDS, AND THEN HANDED IT TO HER DAUGHTER. THE CONSUMER FURTHER STATED THAT THE PRODUCT LEAKED WHILE THE CHILD WAS CARRYING THE PRODUCT, WHICH CAUSED HER INJURIES. THE DIRECTIONS FOR PROPER USE STATES THAT THE PRODUCT SHOULD BE HEATED IN A 1000-1200 WATT MICROWAVE FOR NO MORE THAN 105 SECONDS. KAZ USA, INC. REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR LAB ANALYSIS, BUT THE CONSUMER STATED THAT SHE HAD ALREADY DISCARDED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403714 SMARTTEMP HOT/COLD PACK IRT KAZ USA, INC. HC1201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention