BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC SUN

    MDR report key: 1524815 · Received November 6, 2009

    Report

    Report Number
    1524815
    Event Type
    Injury
    Date Received
    November 6, 2009
    Date of Event
    October 28, 2009
    Report Date
    November 6, 2009
    Manufacturer
    MEDIVANCE, INC
    Product Code
    DWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BEEN ON ARCTIC SUN EXTERNAL COOLING FOR MANAGEMENT OF NEUROGENIC FEVERS FOR 6 DAYS. WHEN PT WAS TURNED ON THE EVENING OF THE 6TH DAY, RN FOUND A LARGE BLISTER ON BACK AND THIGHS WHERE THE COOLING PADS HAD BEEN APPLIED. TWO DAYS LATER THE INJURY WAS DESCRIBED AS FROSTBITE AND MAY BE FULL THICKNESS. FOLLOW-UP TREATMENT WITH SILVADENE AND DEBRIDED A FEW DAYS LATER. CLINICIANS ARE TREATING IT LIKE A BURN.PADS USED WITH THE ARCTIC SUN COOLING DEVICE WERE PRODUCT # 317-00 UNIVERSAL LOT# K9E1804PRODUCT # 317-09 LARGE LOT# K9K0502PADS WERE DISCARDED AT TIME OF INCIDENT.

    Description of Event or Problem · 1

    PATIENT HAD BEEN ON ARCTIC SUN EXTERNAL COOLING FOR MANAGEMENT OF NEUROGENIC FEVERS FOR 6 DAYS. WHEN PT WAS TURNED ON THE EVENING OF THE 6TH DAY, RN FOUND A LARGE BLISTER ON BACK AND THIGHS WHERE THE COOLING PADS HAD BEEN APPLIED. TWO DAYS LATER THE INJURY WAS DESCRIBED AS FROSTBITE AND MAY BE FULL THICKNESS. FOLLOW-UP TREATMENT WITH SILVADENE AND DEBRIDED A FEW DAYS LATER. CLINICIANS ARE TREATING IT LIKE A BURN.PADS USED WITH THE ARCTIC SUN COOLING DEVICE WERE PRODUCT # 317-00 UNIVERSAL LOT# K9E1804PRODUCT # 317-09 LARGE LOT# K9K0502PADS WERE DISCARDED AT TIME OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC SUN SYSTEM, THERMAL REGULATING DWJ MEDIVANCE, INC 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R