BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROAIR HFA

    MDR report key: 3305354 · Received August 22, 2013

    Report

    Report Number
    MW5031537
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Report Date
    August 22, 2013
    Manufacturer
    TEVA RESPIRATORY LLC
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS INTERMITTENT NO DEVICE OUTPUT WHEN SHE PUSHES THE ACTIVATION BUTTON. CALLER STATES THAT SHE SI FAMILIAR WITH THE BRAND OF INHALER AND HAS NOT HAD ISSUES BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409390 PROAIR HFA INHALER CAF TEVA RESPIRATORY LLC NDC59310-579-22

    Patients

    Seq Age Sex Outcome Treatment
    1