BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASE IV

    MDR report key: 1184789 · Received September 29, 2008

    Report

    Report Number
    2118418-2008-00001
    Event Type
    Other
    Date Received
    September 29, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 26, 2008
    Manufacturer
    WR MEDICAL ELECTRONICS CO.
    Product Code
    JXE
    PMA / PMN Number
    910624
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERMAL ELECTRIC UNIT, PELTIER (TEU). AN ONSITE VISIT WAS PERFORMED BY PERSONAL TO EVALUATE THE DEVICE AND IT WAS DETERMINED THE THERMAL ELECTRIC UNIT (TEU) WAS DAMAGED CAUSING AN UNEVEN TEMPERATURE GRADIENT ACROSS THE SURFACE. THIS 'HOT-SPOT' MAY HAVE CAUSED THE REPORTED PATIENT BURN AND THIS DEVICE HAS BEEN TAKEN OUT OF SERVICE. THIS WAS CAUSED BY USER DAMAGE TO THE SURFACE OF THE TEU CAUSING A CRACK IN THE CERAMIC SURFACE. USER WAS INSTRUCTED TO USE LIQUID CRYSTAL THERMAL SHEET TO DETECT UNEVEN TEMPERATURE DURING ROUTINE CALIBRATION VERIFICATION OR ANYTIME SURFACE IS SUSPECT. THIS INFORMATION CAN BE FOUND IN THE DEVICE MANUAL.

    Description of Event or Problem · 1

    DURING TESTING AT HOSPITAL, OF A PATIENT THAT IS A FEMALE, WHO DR. REPORTED AS IN GOOD HEALTH AND PART OF AN ONGOING OUTPATIENT TESTING PROGRAM AT THE CLINIC WAS BURNED USING THE CASE IV DEVICE DURING THE HEAT AS PAIN TEST. HE CONFIRMED THAT SHE PARTICIPATED IN CASE IV TESTS IN 2008. AND REPORTED THE BURN ONE WEEK LATER, FROM WHAT DR. SAID, THE BURN ON HER LEFT HAND IS 3/4 CM X 1/2 CM IN A RECTANGULAR SHAPE AND HAS SCABBED OVER. AN ONSITE VISIT WAS PERFORMED BY PERSONAL TO EVALUATE THE DEVICE AND IT WAS DETERMINED THE THERMAL ELECTRIC UNIT (TEU) WAS DAMAGED CAUSING AN UNEVEN TEMPERATURE GRADIENT ACROSS THE SURFACE. THIS 'HOT-SPOT' MAY HAVE CAUSED THE REPORTED PATIENT BURN AND THIS DEVICE HAS BEEN TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASE IV CASE IV JXE WR MEDICAL ELECTRONICS CO. 5000

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other