BEUDAMED
    FDA Adverse Event Summary report: N

    PROVENTIL HFA INHALATION AEROSOL WITH DOSE INDICATOR

    MDR report key: 7914302 · Received September 26, 2018

    Report

    Report Number
    MW5080157
    Date Received
    September 26, 2018
    Date of Event
    September 25, 2018
    Report Date
    September 25, 2018
    Manufacturer
    MERCK & CO., INC. / MERCK SHARP AND DOHME CORP.
    Product Code
    KCO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NEW INSTRUCTIONS FOR A CHANGED PRODUCT ARE INADEQUATE AND COULD RESULT IN A DISASTER FOR SOME PTS. PROVENTIL HFA INHALER MERCK & CO.: TEMPERATURE LIMITS IN CLEANING STEP 6 OF THE INSTRUCTIONS SUGGESTS THE MEDICINE WILL BE DESTROYED IF CARRIED AT THE HIGH TEMPERATURE POSSIBLE IN A NORMAL POCKET, OVER 25 C, 77 F. THERE IS NO INSTRUCTION TO AVOID THIS OR HOW HIGHER TEMPERATURES WOULD AFFECT THE EFFECTIVENESS OF THE DRUG. UNDER "USING YOUR PROVENTIL HFA INHALER", FIGURE D, THE INHALER DRAWING DOES NOT SHOW "MOUTHPIECE FULLY INTO THE MOUTH" AS THE DRAWING IS FROM SOME OTHER TYPE OF INHALER. IT LOOKS LIKE THE PERSON IS STICKING THEIR TONGUE INTO THE INHALER. TOTALLY WRONG. THEY WOULD DIE. THERE IS NO DEFINITION FOR "FEV" IN THE "CLINICAL TRIALS: SECTION MAKING IT IMPOSSIBLE TO JUDGE THE ACTION OF THIS DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751128 PROVENTIL HFA INHALATION AEROSOL WITH DOSE INDICATOR NASAL INHALER KCO MERCK & CO., INC. / MERCK SHARP AND DOHME CORP. NDC 0085-1132-04 180340

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR