BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3465882 · Received November 5, 2013

    Report

    Report Number
    1054871-2013-00088
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Date of Event
    October 8, 2013
    Report Date
    November 5, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO. LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATHE ATOMIZER ON OCTOBER 8, 2013. THE PATIENT REPORTED THAT THE ATOMIZER DID NOT PRODUCE AN AEROSOL MIST TO ALLEVIATE THE SYMPTOMS OF AN ASTHMA ATTACK. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE AND MAIL UNSUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568720 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO. LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other