BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 3519934 · Received November 9, 2013

    Report

    Report Number
    3005442893-2013-00091
    Event Type
    Injury
    Date Received
    November 9, 2013
    Date of Event
    October 15, 2013
    Report Date
    November 11, 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. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE IDENTIFIED, SINCE THE DEVICE WAS NOT RETURNED. HEREWITH THE INVESTIGATION REPORT AS ATTACHMENT. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATH ATOMIZER ON (B)(6) 2013. THE PATIENT REPORTED THAT THE ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST. IN ADDITION, THE PATIENT ADDED THAT SHE REQUIRED MEDICAL TREATMENT AT THE HOSPITAL. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE AND MAIL UNSUCCESSFULLY. THE INVESTIGATED PRODUCT FOR THE ENCLOSED MEDICAL DEVICE REPORT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MANUFACTURER HEALTH & LIFE, CO. LTD. ON MAY 8, 2013. THE CLASS 1 RECALL (Z-1371-2013, Z-1372-2013, Z-1373-2013) WAS INITIATED AFTER NEPHRON PHARMACEUTICALS CORPORATION, THE IMPORTER, BECAME AWARE OF AN INCREASING NUMBER OF COMPLAINTS ASSOCIATED WITH THE POSSIBILITY OF A QUARTER-INCH WASHER BECOMING DISLODGED FROM THE EZ BREATH ATOMIZER. THE IMPACTED ATOMIZER SERIAL NUMBER RANGES ARE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580261 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 121001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O UNIDENTIFIED