BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3202324 · Received June 25, 2013

    Report

    Report Number
    3005442893-2013-00034
    Date Received
    June 25, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 23, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THIS FAILURE MODE FROM THE DESIGN FAILURE MODES AND EFFECTS ANALYSIS OF THIS PRODUCT, THAT THE USE OF THE PRODUCT IN A MANNER LIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCES IS IMPROBABLE AND THAT NO COMPLAINTS DOCUMENTING DEATHS OR SERIOUS INJURIES HAVE BEEN RECEIVED. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE IDENTIFIED, SINCE THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED (B)(4) REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE CUSTOMER REPORTED THAT SHE ATTEMPTED TO USE THE EZ BREATHE ATOMIZER TO ALLEVIATE SYMPTOMS OF AN ASTHMA ATTACK WITHOUT SUCCESS. SHE REPORTED THAT THE DEVICE FAILED TO PRODUCE A MIST FROM THE ASTHMANEFRIN INHALATION SOLUTION. INSTEAD OF SEEKING MEDICAL ATTENTION, THE PATIENT RETURNED TO (B)(6) IN ORDER TO EXCHANGE THE INVESTIGATED DEVICE FOR A NEW ATOMIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286808 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other ASTHMANEFRIN INHALATION SOLUTION