BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3834812 · Received May 2, 2014

    Report

    Report Number
    1054871-2014-00013
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 2, 2014
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT'S MOTHER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION VIA EMAIL ON (B)(6) 2014, REGARDING A REPORTABLE MALFUNCTION OF NO AEROSOL PRODUCTION THAT WAS REPORTED AS ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PT'S MOTHER REPORTED THAT THE ATOMIZERS DID NOT OPERATE PROPERLY WHILE HER SON EXPERIENCED AN ASTHMA ATTACK. MULTIPLE ATTEMPTS WERE MADE TO REACH THE PT UNSUCCESSFULLY. TWO MEDICAL DEVICE REPORTS WILL BE SUBMITTED TO THE AGENCY, BECAUSE THE RPTR STATED THAT TWO ATOMIZERS FAILED TO FUNCTION. NO ADD'L INFO IS AVAILABLE ABOUT THE PT OR EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264017 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other