BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 2987195 · Received February 28, 2013

    Report

    Report Number
    1054871-2013-00008
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 21, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORP. REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013, VIA TELEPHONE. THE CUSTOMER REPORTED THAT THE WASHER ROLLED THROUGH THE MOUTHPIECE AND FELL FROM THE EZ BREATH ATOMIZER ONTO HIS TONGUE WHILE HE WAS USING THE PRODUCT WITH ASTHMANEFRIN INHALATION SOLUTION. THE CUSTOMER REPORTED THAT HE DID NOT REQUIRE ANY MEDICAL INTERVENTIONS OR HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87484 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other