BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 3472560 · Received October 1, 2013

    Report

    Report Number
    3005442893-2013-00069
    Date Received
    October 1, 2013
    Date of Event
    August 2, 2013
    Report Date
    August 29, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 CONSEQUENCES IS IMPROBABLE. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE IDENTIFIED, SINCE THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER'S SPOUSE CONTACTED NEPHRON PHARMACEUTICALS CORP. REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATH ATOMIZER ON (B)(6) 2013. THE INITIAL REPORTER STATED THAT THE ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST WHILE HER HUSBAND WAS EXPERIENCING AN ASTHMA ATTACK. HER HUSBAND WENT TO THE EMERGENCY DEPARTMENT AT THE HOSPITAL AND REQUIRED NEBULIZER TREATMENTS TO ALLEVIATE HIS ASTHMA SYMPTOMS. THE PATIENT IS A (B)(6) MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. HE IS A NONSMOKER AND REPORTS ALLERGIES TO PENICILLIN. THE INVESTIGATED PRODUCT FOR THE ENCLOSE MEDICAL DEVICE REPORT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MFR HEALTH AND LIFE CO, LTD. ON 05/08/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494897 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120701

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| O INVESTIGATION.| THIS INFORMATION WAS NOT IDENTIFIED DURING THE,