BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAIR HUGGER

    MDR report key: 39799 · Received September 23, 1996

    Report

    Report Number
    39799
    Event Type
    Other
    Date Received
    September 23, 1996
    Date of Event
    August 15, 1996
    Report Date
    September 16, 1996
    Manufacturer
    AUGUSTINE MEDICAL INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS BURNED WHEN FACILITY USED A WARMING UNIT WITHOUT A WARMING BLANKET. INJURY WITHOUT A WARMING BLANKET. INJURY PROGRESSED TO MUSCLE NECROSIS NECESSITATING AMPUTATION. FACILITY REPORT ATTACHED AS PAGES 3 AND 4 OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other