BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCTIC SUN TEMPERATURE MGMT SYSTEM

    MDR report key: 376285 · Received February 8, 2002

    Report

    Report Number
    MW1024043
    Event Type
    Other
    Date Received
    February 8, 2002
    Date of Event
    February 1, 2002
    Report Date
    February 6, 2002
    Manufacturer
    MEDIVANCE, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO SURGERY 2 LARGE ADHESIVE ARCTIC SUN ENERGY TRANSFER PADS APPLIED TO PT'S BACK. CONTROL MODULE TURNED ON. DELIVERS MAX OF 42 DEGREES HEATED H2O THROUGH PADS. PT ON OR TABLE WITH SHOULDER ROLL FOR 10-11 HRS. TWO DAYS LATER REDDENED AREA WITH BLISTERS NOTED OVER RIGHT SCAPULA. THE NEXT DAY SECOND DEGREE "BURN" MEASURED 4 X 5 CM, TREATING WITH OINTMENT. SHOULD HEAL WITHIN 2 WEEKS. HEAT TRANSFER PADS DISCARDED BUT ARCTIC SUN CONTROL MODULE 2097 IS AVAILABLE TO IN-HOUSE REP IN 02/2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC SUN TEMPERATURE MGMT SYSTEM WARM WATER FLOWING THROUGH ADHESIVE WARMING PADS DWJ MEDIVANCE, INC. 100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other