BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROAIR HFA

    MDR report key: 7285534 · Received February 20, 2018

    Report

    Report Number
    MW5075366
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    February 10, 2018
    Report Date
    February 20, 2018
    Manufacturer
    TEVA PHARMACEUTICALS USA
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATED WHILE ATTEMPTING TO USE INHALER, SHE FOUND THE DEVICE WAS DELIVERING A WHITE SUBSTANCE WHICH WAS FOUND CLOGGED WITHIN THE DEVICE. CALLER WAS UNABLE TO RECEIVE HER INHALANT AND EXPERIENCED RESPIRATORY ISSUES. CALLER WAS ADMITTED TO THE HOSPITAL WHERE SHE STAYED OVERNIGHT TO TREAT HER LUNGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126178 PROAIR HFA INHALER CAF TEVA PHARMACEUTICALS USA DAD03A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR