BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC SUN

    MDR report key: 2132618 · Received June 12, 2011

    Report

    Report Number
    MW5020970
    Event Type
    Injury
    Date Received
    June 12, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 12, 2011
    Manufacturer
    MEDIVANCE
    Product Code
    DWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ARCTIC SUN CAUSED 3RD DEGREE BURNS AFTER 10 HOURS OF USE. BASED ON DISCUSSIONS WITH OTHER CENTERS, THIS IS A COMMON OCCURRENCE YET THE COMPANY DOES NOT SEEM TO REPORT THESE ISSUES VIA MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC SUN ARCTIC SUN DWJ MEDIVANCE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization