BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3147551 · Received May 30, 2013

    Report

    Report Number
    1054871-2013-00036
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 23, 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 PRODUCT COMPLAINT ON (B)(6) 2013. THE CUSTOMER REPORTED THAT THE SILVER PIECE FROM THE EZ BREATH ATOMIZER FELL INTO HIS MOUTH DURING USE. NO ADD'L INFO IS AVAILABLE AT THE TIME OF THIS REPORT SINCE ATTEMPTS TO CONTACT THE CUSTOMER WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237869 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other