BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-FLO OXYGEN TUBING

    MDR report key: 33371 · Received June 6, 1996

    Report

    Report Number
    MW1009236
    Event Type
    Malfunction
    Date Received
    June 6, 1996
    Date of Event
    May 23, 1996
    Report Date
    May 24, 1996
    Manufacturer
    B & F MEDICAL PRODUCTS, INC.
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THREE HOME OXYGEN PTS BECAME ILL DUE TO A FOUL, PLASTIC ODOR EMITTED FROM THE OXYGEN TUBING THEY WERE USING. HOME OXYGEN PTS WERE NAUSEATED, SICK, AND DIZZY FROM FOUL FUMES THEY WERE BREATHING WHILE USING THE OXYGEN. REPORTED PROBLEM TO MFR AND THEY WERE ALREADY AWARE OF THE PROBLEM. RPTR FEELS END USERS SHOULD HAVE BEEN NOTIFIED AND PRODUCT SHOULD HAVE BEEN RECALLED. ADD'L EVENT DATE 5/24/96, 2 FEMALES, 1 MALE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE-FLO OXYGEN TUBING OXYGEN TUBING CAT B & F MEDICAL PRODUCTS, INC. 64232 013670

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO