BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 2974254 · Received February 21, 2013

    Report

    Report Number
    1054871-2013-00005
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 13, 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 ON (B)(6) 2013. THE CUSTOMER REPORTED THAT HE FELT SOMETHING IN HIS MOUTH WHILE USING THE EZ BREATHE ATOMIZER. HE REMOVED THE WASHER FROM HIS MOUTH. THE CUSTOMER WAS CONTACTED AND REPORTED THAT HE DID NOT SUFFER ANY HARM OR REQUIRE ANY MEDICATION INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75361 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other UNIDENTIFIED