BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3365241 · Received September 23, 2013

    Report

    Report Number
    1054871-2013-00071
    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 BREATH ATOMIZER ON (B)(6) 2013. SHE REPORTED THAT THE ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST DURING AN EPISODE OF RESPIRATORY DISTRESS, AND SHE REQUIRED MEDICAL TREATMENT AT THE EMERGENCY ROOM. SHE ADDED THAT SHE CLEANED THE ATOMIZER ACCORDING TO THE COMPANY'S INSTRUCTIONS. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE UNSUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479700 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO LTD EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O