BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3769402 · Received April 14, 2014

    Report

    Report Number
    1054871-2014-00010
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 14, 2014
    Manufacturer
    HEALTH AND 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 PT CONTACTED NEPHRON PHARMACEUTICALS CORPORATION 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 REPORTED THAT HE REQUIRED MEDICAL TREATMENT AT THE HOSPITAL AFTER THE ATOMIZER FAILED TO FUNCTION. DURING A FOLLOW-UP PHONE CALL ON (B)(6) 2014, THE PT REPORTED THAT THE ATOMIZER DID NOT PRODUCE A MIST TO ALLEVIATE HIS ASTHMA SYMPTOMS. HE ADDED THAT THE SOLUTION DRIPPED OUT OF THE FRONT OF THE ATOMIZER. THE PT STATED THAT HE CLEANED THE ATOMIZER ACCORDING TO THE PRODUCT'S INSTRUCTIONS. THE PT USED THE DEVICE THREE TIMES SUCCESSFULLY; HOWEVER, THE DEVICE FAILED TO FUNCTION DURING HIS FOURTH TREATMENT. THE PT IS A 43 YEAR OLD MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. HE IS A FORMER SMOKER. THE PT REPORTED THAT A WOOD FIRE NEAR HIS HOME EXACERBATED HIS ASTHMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228570 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH AND LIFE (SUZHOU) CO., LTD. EZ-100 130101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MEDICAL PRODUCTS.| NO INFO WAS AVAILABLE CONCERNING CONCOMITANT