BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAIR HUGGER WARMING SYSTEM

    MDR report key: 276606 · Received May 3, 2000

    Report

    Report Number
    2183725-2000-00001
    Event Type
    Other
    Date Received
    May 3, 2000
    Date of Event
    September 25, 1998
    Report Date
    May 3, 2000
    Manufacturer
    AUGUSTINE MEDICAL INC.
    Product Code
    DWJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SURGERY AS THE RESULT OF A CAR ACCIDENT. PT WAS WARMED DURING SURGERY WITH A 200 SERIES WARMING UNIT WITH NO BLANKET ATTACHED. PT SUSTAINED SECOND AND THIRD DEGREE BURNS ON THE LOWER EXTREMITIES. BURNS CAUSED BY PRODUCT MISUSE: WARNINGS ARE PROVIDED ON EVERY WARMING UNIT, IN INSTRUCTIONS FOR USE PACKAGED WITH EVERY BLANKET, ON A LABEL ATTACHED TO EVERY BLANKET, IN THE OPERATIONS MANUAL AND IN THE SERVICE MANUAL STATING THAT SERIES 200 WARMING UNITS ARE NOT TO BE USED IN OPERATING ROOMS AND THAT A BLANKET MUST BE ATTACHED TO THE HOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER WARMING SYSTEM WARMING UNIT DWJ AUGUSTINE MEDICAL INC. 200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other