BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAIR HUGGER

    MDR report key: 374310 · Received January 26, 2002

    Report

    Report Number
    MW1023924
    Event Type
    Injury
    Date Received
    January 26, 2002
    Date of Event
    November 30, 2001
    Report Date
    January 26, 2002
    Manufacturer
    AUGUSTINE MEDICAL INC
    Product Code
    DWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD RED BLOTCHES NOTED TO UPPER BACK AND ARMS. BLISTERS DEVELOPED AND WHELPS AFTER USE OF BAIR HUGGER HYPERTHERMIA UNIT AND UPPER BODY BLANKET (DISPOSABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER HYPERTHERMIA UNIT (FORCED AIR) DWJ AUGUSTINE MEDICAL INC 500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention