BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEROCHAMBER W/MASK

    MDR report key: 299335 · Received October 6, 2000

    Report

    Report Number
    MW1020092
    Event Type
    Injury
    Date Received
    October 6, 2000
    Date of Event
    March 1, 1999
    Report Date
    October 6, 2000
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Product Code
    CCQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE RPTR IS CONCERNED ABOUT WHAT THEY CONSIDER TO BE A DESIGN FLAW WITH THIS DEVICE. THE EXHALATION VALVE HAS A FLAP REQUIRING THE CHILD TO INHALE THROUGH THEIR MOUTH TO ENSURE THAT THEY RECEIVE THE MEDICATIONS. THIS FLAP FALLS OFF FREQUENTLY AND IS EASILY OVERLOOKED, RESULTING IN NON-DELIVERY OF MEDICATION, AND IN THE RPTR'S CASE, THE CHILD BECOMES ILL. THE RPTR IS ESPECIALLY CONCERNED ABOUT THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROCHAMBER W/MASK SPACING DEVICE CCQ MONAGHAN MEDICAL CORP. NA 00501

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR 2) INTAL-INHALER 3/99.| 1) ALBUTEROL,