BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3233539 · Received July 15, 2013

    Report

    Report Number
    1054871-2013-00051
    Date Received
    July 15, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 15, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED (B)(4) REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATHE ATOMIZER ON (B)(6) 2013. SHE REPORTED THAT HER HUSBAND SWALLOWED A WASHER AND COUGHED IT BACK UP. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE UNSUCCESSFULLY. IN ADDITION, IT WAS DETERMINED THAT THE INVESTIGATED PRODUCT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MANUFACTURER HEALTH AND LIFE, CO., LTD., ON (B)(4) 2013. THE CLASS 1 RECALL (Z-1371-2013, Z-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
    326126 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 121001

    Patients

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