BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3135444 · Received May 29, 2013

    Report

    Report Number
    1054871-2013-00032
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 21, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO, LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE CUSTOMER REPORTED THAT HER HUSBAND USED THE EZ BREATHE ATOMIZER TO INHALE ASTHMANEFRIN INHALATION SOLUTION. DURING ONE TREATMENT, SHE STATED THAT SHE SAW HER HUSBAND GAGGING AFTER INHALING FROM THE ATOMIZER. AFTER EXERTION, THE PT WAS ABLE TO COUGH THE WASHER UP FROM HIS THROAT. THE PT THEN OBTAINED A SECOND ATOMIZER TO USE, AND THE WASHER ALSO FELL OUT OF THIS ATOMIZER DURING USE. THE PT DID NOT REQUIRED ANY MEDICAL INTERVENTION OR HOSPITALIZATION DURING THE COURSE OF THE INVESTIGATION. BOTH ATOMIZERS ARE BEING REPORTED SINCE THE INITIAL RPTR WAS UNABLE TO DETERMINE THE SERIAL NUMBER OF THE ATOMIZER THAT WAS REPORTED AS CAUSING THE PT TO GAG FROM THE LOOSE WASHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236766 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO, LTD. EZ-100 120601

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other THERE WERE NO CONCOMITANT MEDICAL PRODUCTS| BEYOND ASTHMANEFRIN INHALATION SOLUTION.