BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3251598 · Received July 24, 2013

    Report

    Report Number
    1054871-2013-00059
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 24, 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 (B)(4) REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. HE REPORTED THAT A SILVER CIRCULAR RING AND A PLASTIC STRIP FELL FROM THE EZ BREATHE ATOMIZER INTO HIS MOUTH WHILE USING THE MEDICAL DEVICE. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE AND BY MAIL UNSUCCESSFULLY. THE INVESTIGATED PRODUCT THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MANUFACTURER HEALTH AND LIFE CO., LTD., ON (B)(4) 2013. THE CLASS I RECALL (Z-1371-2013, X-1372-2013, Z-1373-2013) WAS INITIATED AFTER (B)(4), THE IMPORTER, BECAME AWARE OF AN INCREASING NUMBER OF COMPLAINTS ASSOCIATED WITH THE POSSIBILITY OF A QUARTER-INCH WASHER BECOMING DISLODGED FROM THE EZ BREATHE ATOMIZER. THE IMPACTED ATOMIZER SERIAL NUMBER RANGES ARE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344926 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other INVESTIGATION| THIS INFORMATION WAS NOT IDENTIFIED DURING THE