BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAIR HUGGER WARMING SYSTEM

    MDR report key: 431516 · Received December 6, 2002

    Report

    Report Number
    2183725-2002-00002
    Event Type
    Other
    Date Received
    December 6, 2002
    Date of Event
    October 7, 2002
    Report Date
    December 6, 2002
    Manufacturer
    AUGUSTINE MEDICAL INC.
    Product Code
    DWJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED AS A RESULT OF AN AUTOMOBILE ACCIDENT. PT BECAME HYPOTHERMIC SO WARMING WAS INITIATED. WARMING UNIT WAS USED WITH NO BLANKET ATTACHED. RESULTED IN 2ND AND 3RD DEGREE BURNS TO PT'S INNER THIGHS.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED AS A RESULT OF AN AUTOMOBILE ACCIDENT. PATIENT BECAME HYPOTHERMICA SO WARMING WAS INITIATED. WARMIN UNIT WAS USED WITH NO BLANKET ATTACHED. RESULTED IN 2ND AND 3RD DEGREE BURNS TO PATIENTS INNER THIGHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER WARMING SYSTEM WARMING UNIT DWJ AUGUSTINE MEDICAL INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other