BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3177971 · Received June 19, 2013

    Report

    Report Number
    1054871-2013-00044
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 10, 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 CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE CUSTOMER REPORTED THAT A WASHER FELL FROM THE BREATH ATOMIZER INTO HIS MOUTH WHILE HE WAS INHALING THROUGH THE DEVICE. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER VIA TELEPHONE; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277413 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD EZ-100 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other UNIDENTIFIED