BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVENTIL HFA

    MDR report key: 2163547 · Received July 7, 2011

    Report

    Report Number
    MW5021310
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    SCHERING-PLOUGH
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PROVENTIL MDI DID NOT FUNCTION PROPERLY. MEDICATION WOULD RELEASE AFTER THE CANISTER WAS PRESSED. PT CHECK TO SEE IF VALVE WAS CLOGGED OR FOR OTHER OBJECTS OBSTRUCTING MEDICATION PASSAGE. NONE NOTED. DOSE: 2 PUFFS EVERY 4 HOURS. DATES OF USE: (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: ASTHMA - SHORTNESS OF BREATH. SECOND CANISTER PT BROUGHT BACK TO PHARMACY AS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVENTIL HFA ALBUTEROL SULFATE 108 MCG CCQ SCHERING-PLOUGH 100516

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR