BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 2987191 · Received February 28, 2013

    Report

    Report Number
    1054871-2013-00006
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 21, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORP. REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013, VIA (B)(4) AND TELEPHONE. THE CUSTOMER REPORTED THAT SHE PURCHASED TWO EZ BREATHE ATOMIZERS THAT DID NOT PRODUCE AN AEROSOL. SHE ALSO REPORTED THAT SHE EXPERIENCED AN ASTHMA ATTACK AND RUSHED TO THE HOSPITAL. SEVERAL ATTEMPTS VIA TELEPHONE AND MAIL WERE MADE TO CONTACT THE CUSTOMER; HOWEVER, ALL ATTEMPTS TO CONFIRM THE CUSTOMER'S COMPLAINT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86799 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK