BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3312684 · Received August 22, 2013

    Report

    Report Number
    1054871-2013-00068
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 31, 2013
    Report Date
    August 22, 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 BREATHE ATOMIZER ON (B)(6) 2013. THE CUSTOMER REPORTED THAT HE USED THE EZ BREATHE ATOMIZER AFTER RECEIVING THE NEW REPLACEMENT PACKAGE AND REALIZED THAT HE SWALLOWED AN UNIDENTIFIED OBJECT AFTER USING THE DEVICE. AFTER INSPECTING THE DEVICE, THE CUSTOMER REPORTED THAT ALL COMPONENTS APPEARED TO BE INTACT. THE PT REFUSED TO SEEK A MEDICAL ASSESSMENT TO DETERMINE IF HE DID INGEST ANY COMPONENTS OF THE ATOMIZER. THE PT IS A MALE OF AN UNIDENTIFIED AGE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408514 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 121202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ASTHMANEFRIN INHALATION SOLUTION, 2.25%