BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAIR HUGGER 500 SERIES

    MDR report key: 39802 · Received September 23, 1996

    Report

    Report Number
    2183725-1996-00003
    Event Type
    Injury
    Date Received
    September 23, 1996
    Date of Event
    August 15, 1996
    Report Date
    September 9, 1996
    Manufacturer
    AUGUSTINE MEDICAL, INC
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL REPAIR OF A JUXTARENAL ABDOMINAL AORTIC ANEURYSM, THE HOSE OF THE BLANKET WAS PLACED UNDER THE PT'S CLOTH BLANKET, WITHOUT USING THE BLANKET. A BURN WAS NOTED ON THE PT'S LOWER LEG. THE INJURY PROGRESSED TO MUSCLE NECROSIS NECESSITATING ABOVE THE KNEE AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER 500 SERIES WARMING BLANKET DWJ AUGUSTINE MEDICAL, INC 500/OR *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R| S