BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATOMIZER EZ100

    MDR report key: 3519433 · Received December 5, 2013

    Report

    Report Number
    MW5033364
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Date of Event
    December 1, 2013
    Report Date
    December 4, 2013
    Manufacturer
    NEPHRON PHARMACEUTICALS
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED THIS ATOMIZER APPROX ONE MONTH AGO, SINCE THAT TIME, IT HAS BEEN TOUCH AND GO. SOMETIMES IT WORKS AND SOMETIMES IT WON'T. IT JUST QUIT FUNCTIONING. I PAID (B)(6) FOR THIS PRODUCT AND MY QUESTION IS, IF THIS IS BEING RECALLED, WHY IS IT STILL ON THE MARKET AND IN ONE OF AMERICA'S LARGEST DRUG RETAILERS (B)(4)?. DATES OF USE: (B)(6) 2013. REASON FOR USE: SHORT OF OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631535 ATOMIZER EZ100 ATOMIZER EZ100 CCQ NEPHRON PHARMACEUTICALS EZ100

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other NEPHRON PHARMECEUTICALS| ASTHMANEPRINE ATOMIZER 2.5 MG