BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT WARMING DEVICE

    MDR report key: 216541 · Received March 26, 1999

    Report

    Report Number
    MW1016007
    Event Type
    Injury
    Date Received
    March 26, 1999
    Date of Event
    March 10, 1999
    Report Date
    March 26, 1999
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SECOND DEGREE BURN ON A PT. HOSP MEMORANDUM STATES, "BAIR HUGGER UNITS ARE CURRENTLY BEING UTILIZED INTRAOPERATIVELY FOR SURGICAL PTS. RECENTLY WE HAD AN INCIDENT RESULTING IN A 2ND DEGREE BURN ON A PT. PROCEDURES HAVE BEEN FOLLOWED FOR INVESTIGATION WITH THE UNIT INVOLVED AND PRELIMINARY REPORTS INDICATE THE UNIT WAS FUNCTIONING PROPERLY AND WITHIN SPECS. MFR'S GUIDELINES WERE FOLLOWED FOR USE OF THIS UNIT WHEN THEIS INCIDENT OCCURRED. A REP FROM AUGUSTINE MEDICAL, INC WILL BE IN THE OR ON WEDNESDAY, MARCH 24, 1999 TO REVIEW PROCEDURES/PRECAUTIONS WITH USE OF THESE WARNING DEVICES. UNTIL COMPLETION OF THE INVESTIGATION FROM AUGUSTINE MEDICAL, INC, PLEASE UTILIZE TEMP SELECTION ON MEDIUM OR LOW ONLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT WARMING DEVICE BAIR HUGGER TEMPERATURE UNIT DWJ AUGUSTINE MEDICAL, INC. 500 BAIR HUGGER *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention