BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3247819 · Received July 12, 2013

    Report

    Report Number
    3005442893-2013-00041
    Date Received
    July 12, 2013
    Date of Event
    March 17, 2013
    Report Date
    June 10, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THIS FAILURE MODE FROM THE DESIGN FAILURE MODES AND EFFECTS ANALYSIS OF THIS PRODUCT, THAT THE USE OF THE PRODUCT IN A MANNER LIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCE IS IMPROBABLE AND THAT NO COMPLAINTS DOCUMENTING DEATHS OR SERIOUS INJURIES HAVE BEEN REC'D. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE IDENTIFIED, SINCE THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE CUSTOMER REPORTED THAT THE EZ BREATHE ATOMIZER FAILED TO PRODUCE A SUFFICIENT MIST TO ALLEVIATE HER ASTHMA SYMPTOMS. THE PT ADDED THAT THE PRODUCT MALFUNCTION CAUSED HER TO BE HOSPITALIZED FOR AN ASTHMA ATTACK. THE PT CALLED NEPHRON PHARMACEUTICALS CORPORATION TO REPORT TWO INCIDENTS OF HOSPITALIZATION FOR TWO SEPARATE DEVICES ON (B)(6) 2013. THEREFORE, TWO 30-DAY MEDWATCH FORMS WILL BE SUBMITTED FOR THIS INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324863 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other THIS INFO WAS NOT IDENTIFIED DURING THE INVESTIGAT