BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROAIR HFA (90 MCG)

    MDR report key: 2249857 · Received September 11, 2011

    Report

    Report Number
    MW5022218
    Event Type
    Malfunction
    Date Received
    September 11, 2011
    Date of Event
    September 11, 2011
    Report Date
    September 11, 2011
    Manufacturer
    IVAX WATERFORD, IRELAND FOR TEVA RESPIRATORY LLC
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PROAIR HFA INHALER LOT PAA37B EXP. 06/2012 INHALER WILL NOT DISPENSE DOSE OF ALBUTEROL. THIS IS A BRAND NEW INHALER TRIED FOR THE FIRST TIME. PT BOUGHT BACK ANOTHER INHALER FROM THE SAME LOT DUE TO PROBLEMS, SOME LEAKAGE NOTED AROUND STEM OF CANNISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROAIR HFA (90 MCG) INHALER CCQ IVAX WATERFORD, IRELAND FOR TEVA RESPIRATORY LLC PAA37B

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR