BEUDAMED
    FDA Adverse Event Other Summary report: N

    KAZ SMARTTEMP

    MDR report key: 1662767 · Received April 15, 2010

    Report

    Report Number
    1314800-2008-00008
    Event Type
    Other
    Date Received
    April 15, 2010
    Date of Event
    November 4, 2008
    Report Date
    April 9, 2010
    Manufacturer
    KAZ, INC.
    Product Code
    IMD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER CLAIMS TO HAVE RECEIVED A FREEZER BURN FROM LEAKING GEL PACK. GEL LEAKED ONTO CONSUMERS ARM CAUSING PAIN AND SWELLING AND COULD NOT REMOVE THE GEL. SHE DID NOT SEEK MEDICAL ATTENTION FOR THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAZ SMARTTEMP COLD PACK IMD KAZ, INC. HC1422 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other