BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 3480447 · Received November 8, 2013

    Report

    Report Number
    1054871-2013-00090
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    October 13, 2013
    Report Date
    November 11, 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. THE PT STATED SHE OPENED THE ATOMIZER CONTAINER AND ATTEMPTED TO USE THE NEW ATOMIZER TO ALLEVIATE THE SYMPTOMS OF AN ASTHMA ATTACK; HOWEVER, SHE ADDED THAT THE NEW ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST. THE PT STATED THAT SHE REPLACED THE BATTERY AND CLEANED THE UNIT; HOWEVER, THE ATOMIZER DID NOT PRODUCE AN AEROSOL MIST. AFTER SEVERAL ATTEMPTS, THE PT REPORTED THAT SHE WENT TO THE URGENT CARE CENTER AT THE HOSPITAL TO RECEIVE MEDICAL TREATMENT ON (B)(6) 2013. THE PT IS A (B)(6) FEMALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. SHE ADDED THAT SHE DOES NOT SMOKE. THE PT USED THE PRODUCT TO ALLEVIATE HER ASTHMA SYMPTOMS IN LIEU OF HER PRESCRIPTION INHALER, BECAUSE SHE DID NOT HAVE AN INHALER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578923 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 121202

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other ASTHMANEFRIN INHALATION SOLUTION