BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3424691 · Received October 23, 2013

    Report

    Report Number
    1054871-2013-00074
    Event Type
    Malfunction
    Date Received
    October 23, 2013
    Date of Event
    August 26, 2013
    Report Date
    September 23, 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 CORP REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATH ATOMIZER ON (B)(6) 2013. THE PT REPORTED THAT A SILVER WASHER FELL FROM THE DEVICE INTO HIS MOUTH DURING USE. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE UNSUCCESSFULLY. THE INVESTIGATED PRODUCT FOR THE ENCLOSED MEDICAL DEVICE REPORT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MFR HEALTH AND LIFE COL, LTD., ON MAY 8, 2013. THE CLASS 1 RECALL (Z-1371-2013, Z-1372-2013, Z-1373-2013) WAS INITIATED AFTER (B)(6), 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
    544209 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other UNIDENTIFIED