BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROAIR HFA

    MDR report key: 6128630 · Received November 25, 2016

    Report

    Report Number
    MW5066332
    Event Type
    Injury
    Date Received
    November 25, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 25, 2016
    Manufacturer
    TEVA RESPIRATORY, LLC
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT THE INHALER PRESCRIBED FOR HIS ASTHMA PROAIR HFA DOES NOT RELIEVE HIS ASTHMA ATTACKS (REPORTER IS PRESCRIBED TWO PUFFS PER ATTACK). HE SAYS IT INSTEAD MAKES HIS ATTACKS WORSE. HE SAYS THIS SEEMS TO BE THE NORM WITH THIS PARTICULAR INHALER AS SO MANY OTHERS HAVE GIVEN THE SAME COMPLAINT VIA THE INTERNET. HE IS REQUESTING THAT FDA GET THIS PARTICULAR PRODUCT OFF THE MARKET BECAUSE ACCORDING TO HIM, THERE ARE MANY OTHER INHALERS THAT WORK VERY EFFECTIVELY AND PROAIR HFA IS NOT ONE OF THEM. HE SAYS ALLOWING THIS PRODUCT ON THE MARKET WILL END UP KILLING INNOCENT PEOPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777874 PROAIR HFA INHALER, NEBULIZER CAF TEVA RESPIRATORY, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR