BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTTEMP

    MDR report key: 2042227 · Received March 30, 2011

    Report

    Report Number
    1314800-2011-00017
    Event Type
    Other
    Date Received
    March 30, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 23, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    IME
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE HOT/COLD GEL PACK WAS LEAKING FORM THE SEAM AND HE WAS BURNED FROM THE HOT GEL. HE RECEIVED 2ND DEGREE BURNS TO HIS HAND WHEN HE REACHED INTO THE MICROWAVE TO RETRIEVE THE PACK. HE DID NOT SEEK MEDICAL ATTENTION FOR HIS BURN AS THE INJURY IS HEALING ON IT'S OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTTEMP HOT/COLD PACK IME KAZ, INC. HC1520 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other