BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROCHAMBER

    MDR report key: 233900 · Received July 28, 1999

    Report

    Report Number
    MW1016833
    Event Type
    Malfunction
    Date Received
    July 28, 1999
    Report Date
    July 28, 1999
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT IS A DEVCIE, BUT IS ASSIGNED AN "NDC"#. THE "NDC"# IS DIFFICULT TO FIND ON THE CARTON. IT IS LOCATED WHERE THE PATENT NUMBERS ARE LISTED ADN CAN BE EASILY MISTAKEN FOR A PATENT NUMBER. IT WOULD BE BETTER IF IT WERE MORE PROMINENT. PERHAPS IT COULD BE RELOCATED TO APPEAR IN A CORNER. (PRESENT SAMPLE IS BEING DISPENSED TO A PT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROCHAMBER DEVICE TO AID DELIVERY OF AEROSOL DRUGS CAF MONAGHAN MEDICAL CORP. * 90305

    Patients

    Seq Age Sex Outcome Treatment
    1 *