BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3027650 · Received March 28, 2013

    Report

    Report Number
    1054871-2013-00014
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 22, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION VIA TELEPHONE REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. HE REPORTED THAT A SILVER PIECE FELL INTO HIS MOUTH WHILE USING THE EZ BREATHE ATOMIZER. THE CUSTOMER WAS CONTACTED AND CONFIRMED THAT HE DID NOT REQUIRE ANY MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128155 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other ASTHMANEFRIN INHALATION SOLUTION| ALBUTEROL SULFATE INHALATION SOULTION