BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIN-O-VAC

    MDR report key: 109592 · Received July 25, 1997

    Report

    Report Number
    109592
    Event Type
    Injury
    Date Received
    July 25, 1997
    Date of Event
    July 14, 1997
    Report Date
    July 24, 1997
    Manufacturer
    LABELED "CIG" AUSTRALIA
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TWIN-O-VAC ATTACHED TO POLE OF INFANT WARMER IS USED EITHER TO DELIVER OXYGEN OR TO SUCTION. CAREGIVER, INTENDING TO SUCTION HOOKED TUBING UP TO OUTLET LABELED "OXYGEN" CAREGIVER UNABLE TO SEE OUTLET LABELED SUCTION DUE TO POSITION OF OUTLET AND POSITION OF LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWIN-O-VAC * FMT LABELED "CIG" AUSTRALIA * 521662

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Hospitalization| L