BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLAR PAK COLD APPLICATION

    MDR report key: 19459 · Received February 6, 1995

    Report

    Report Number
    MW1005041
    Event Type
    Other
    Date Received
    February 6, 1995
    Date of Event
    December 30, 1994
    Report Date
    January 23, 1995
    Manufacturer
    BREG, INC.
    Product Code
    ILO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR STATES DEVICE PLACED ON LEFT KNEE AFTER TOTAL KNEE REPLACEMENT. ON 12/30/94, THE PT CLAIMS HE AWOKE FROM SLEEP BECAUSE HIS LEG WAS BURNING. DEVICE HAD WARM WATER (ICE HAD MELTED) AND TEMPERATURE WAS AT HIGHEST SETTING OF 50 DEGREE F. PT HAD 1ST DEGREE SUPERFICIAL BURN ON MEDIAL SIDE OF KNEE. RPTR STATES MACHINE SHOULD NOT HEAT UP ENOUGH TO CAUSE BURN EVEN IF ICE MELTS. PT SAW ORTHOPEDIC SURGEON ON 11/10/95. PT HAD 2 SMALL BLISTERS; RPTR SPOKE TO PT ON 11/16/95. BLISTER WAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR PAK COLD APPLICATION COLD APPLICATION ILO BREG, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other