BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLAR CARE 300

    MDR report key: 3573285 · Received January 13, 2014

    Report

    Report Number
    MW5033821
    Event Type
    Other
    Date Received
    January 13, 2014
    Date of Event
    October 8, 2010
    Report Date
    January 13, 2014
    Manufacturer
    BREG INC.
    Product Code
    ILO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2010 PATIENT HAD ARTHROSCOPIC KNEE SURGERY, FIRST ON HER LEFT KNEE AND THEN ON HER RIGHT KNEE. PT USED THE POLAR CARE 300 ON THE LEFT KNEE WITHOUT ANY ISSUES BUT WHEN PATIENT USED IT ON THE RIGHT KNEE THE MACHINE "MALFUNCTIONED." PT WENT TO DR (B)(6) AND WAS DIAGNOSED WITH TISSUE DAMAGE, SWELLING (3X IT'S NORMAL SIZE), AND "FREEZER BURN" (SECOND DEGREE BURN) LIKE DAMAGE TO THE SKIN. PT ALSO WENT TO A DERMATOLOGIST TO ADDRESS THE SKIN DISCOLORATION AND TISSUE DAMAGE WHICH SHE STILL HAS TO THIS DAY. SHE IS STILL IN PHYSICAL THERAPY, ACUPUNCTURE ALMOST FOUR YEARS LATER DUE TO THE MALFUNCTION OF THE POLAR CARE 300 AND WILL NEED MEDICAL CARE FOR THE REST OF HER LIFE. PT STATES "THIS PRODUCT IS NOT SAFE TO BE ON THE MARKET. IT HAS NO SAFETY VALVE, AND MEDICARE SHOULD NOT PAY FOR THE USE OF THIS MACHINE." PT ALSO STATES THAT THE DAMAGE TO HER KNEE HAS CAUSED "HEMORRHAGING IN HER KNEE WHICH CAUSES BLOOD TO COLLECT IN HER RIGHT FOOT. (TURN BLACK)." PT HAS ALREADY INFORMED MANUFACTURER. PT IS WILLING TO PROVIDE ANY ADD'L INFO AS WELL AS PICTURES. POLAR CARE 300 WAS DELIVERED TO THE PATIENT. BY A THIRD PARTY COMPANY- (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33030 POLAR CARE 300 PACK, HOT/COLD WATER CIRCULATING ILO BREG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1