BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATH ATOMIZER & 10 ASTHMANEFRIN VIALS (STARTER KIT)

    MDR report key: 3242768 · Received July 18, 2013

    Report

    Report Number
    MW5030971
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 15, 2013
    Report Date
    July 7, 2013
    Manufacturer
    NEPHRON PHARMACEUTICALS CORP
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BOUGHT THE UNIT IN (B)(6) 2013. USED IT SEVERAL TIMES BEFORE CLEANING IT PER INSTRUCTIONS. IT WORKED WELL UNTIL I CLEANED IT. DIDN'T NEED AGAIN UNTIL (B)(6) 2013 AND THEN IT STOPPED WORKING ALL TOGETHER. NO MEDICATION EMITTED FROM ATOMIZER. RACEPINEPHRINE 2.25% 0.5ML CONTAINS 11.25MG, 1-3 INHALATIONS EVERY 3 HOURS, NO MORE THAN 12 INHALATIONS IN 24 HOURS, BY MOUTH, DATE THE PERSON FIRST STARTED TAKING: (B)(6) 2013, DATE THE PERSON STOPPED TAKING: (B)(6) 2013. WAS HAVING SEVERE ASTHMA AND UNIT COMPLETELY STOPPED WORKING AFTER BEING CLEANED PER INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335440 EZ BREATH ATOMIZER & 10 ASTHMANEFRIN VIALS (STARTER KIT) EZ BREATH ATOMIZER & 10 ASTHMANEFRIN VIALS (STARTER KIT) CCQ NEPHRON PHARMACEUTICALS CORP R2048A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other FISH OIL (OMEGA 3)| VITAMIN D| CLONIDINE| BENADRYL| ROBAXIN| BRONKAID| CLONAZEPAM| SERTRALINE| FLAXSEED OIL| ZYRTEC