BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3281910 · Received August 1, 2013

    Report

    Report Number
    1054871-2013-00063
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 9, 2013
    Report Date
    August 1, 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 BREATH ATOMIZER ON (B)(6) 2013. HE REPORTED THAT A WASHER FELL FROM THE EZ BREATHE ATOMIZER INTO HIS MOUTH WHILE USING THE DEVICE. HE RECOVERED THE COMPONENT WITHOUT REQUIRING ANY MEDICAL INTERVENTIONS. THE PT IS A (B)(6) MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR EMPHYSEMA. HE IS A CURRENT SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361491 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO, LTD EZ-100 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other ASTHMANEFRIN INHALATION SOLUTION