BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 661657 · Received January 5, 2006

    Report

    Report Number
    1725056-2006-00001
    Event Type
    Injury
    Date Received
    January 5, 2006
    Date of Event
    December 5, 2005
    Report Date
    January 5, 2006
    Manufacturer
    MEDIVANCE, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HOSPITALIZED IN 11/05 FOR A BURST ARTERIO-VENOUS FORMATION. THE PATIENT EXHIBITED NERUOGENIC FEVER DURING HIS STAY IN THE NEURO-ICU. THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM WAS APPLIED TO THE PATIENT IN 11/05 TO CONTROL THE PATIENT'S TEMPERATURE. IN 05, THE NURSING STAFF NOTED A SKIN PRESSURE POINT ON THE SCAPULA UNDER THE DEVICE AND DRESSED THE AREA. THE NEXT DAY, THE NURSING STAFF NOTED THAT THE SKIN ON THE THIGHS UNDER THE DEVICE WERE MOTTLED WITH SKIN BREAKDOWN, WHICH REQUIRED DEBRIDEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention