BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEROCHAMBER WITH MASK

    MDR report key: 235302 · Received August 11, 1999

    Report

    Report Number
    MW1016928
    Event Type
    Injury
    Date Received
    August 11, 1999
    Date of Event
    August 2, 1999
    Report Date
    August 11, 1999
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER WAS IN THE MIDDLE OF GIVING SON HIS BREATHING TREATMENT WHEN THE NOSE VALVE DISCONNECTED FROM THE MASK. REPORTER GRABBED CONNECTOR BEFORE IT COULD BE INHALED OR SWALLOWED. REPORTER EXPRESSES CONCERN THAT PIECE CAN BE SO EASILY DISLODGED WITH BREATHING OR CRYING. REPORTER STATES THAT CO ALSO HAS TWO OTHER SIZES OF THIS DEVICE AND SHE IS CONCERNED THAT THEY TOO MIGHT HAVE THE SAME PROBLEM. SHE USES THE SIZE INDICATED BY THE COLOR YELLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROCHAMBER WITH MASK METERED DOSE INHALER CCQ MONAGHAN MEDICAL CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Required Intervention INTAL