BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3365227 · Received September 23, 2013

    Report

    Report Number
    1054871-2013-00072
    Event Type
    Injury
    Date Received
    September 23, 2013
    Date of Event
    August 13, 2013
    Report Date
    September 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 PT CONTACTED NEPHRON PHARMACEUTICALS CORP REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATHE ATOMIZER ON (B)(6) 2013. THE PT REPORTED THAT THE ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST TO ALLEVIATE HIS ASTHMA SYMPTOMS AFTER CLEANING THE DEVICE ACCORDING TO THE COMPANY'S CLEANING INSTRUCTIONS. THE PT ADDED THAT HE REQUIRED MEDICAL TREATMENT AT THE HOSPITAL FOR HIS ASTHMA EXACERBATION. THE PT IS A (B)(6) MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. HE DOES NOT REPORT ANY ALLERGIES TO MEDICATIONS AND ADDS THAT HE IS A NONSMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479805 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO, LTD EZ-100 121102

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O