BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3195252 · Received June 7, 2013

    Report

    Report Number
    1054871-2013-00026
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 7, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO. LTD
    Product Code
    CCQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING AN ADVERSE DRUG EXPERIENCE AND PRODUCT COMPLAINT ON (B)(6) 2013. THE PT REPORTED THAT SHE EXPERIENCED JITTERINESS AND HEADACHES DURING THE INITIAL USE OF ASTHMANEFRIN INHALATION SOLUTION VIA THE EZ BREATHE ATOMIZER; HOWEVER, SHE REPORTED THAT HER BREATHING IMPROVED. AFTER THREE USES OF THE PRODUCT, THE CUSTOMER REPORTED THAT THE ATOMIZER WOULD ONLY PRODUCE A SMALL AMOUNT OF AEROSOL. SHE TOOK THE ASTHMANEFRIN AND EZ BREATH ATOMIZER TO HER JOB SINCE SHE WAS HAVING TROUBLE BREATHING. SHE REPORTED THAT THE ATOMIZER WOULD ONLY PRODUCE A SMALL AMOUNT OF MIST, AND THE MIST WAS INSUFFICIENT TO ALLEVIATE HER ASTHMA SYMPTOMS. AS A RESULT OF THE DEVICE'S PERFORMANCE, THE CUSTOMER REPORTED THAT SHE SUFFERED ASTHMA PROBLEMS FROM TUESDAY EVENING UNTIL WEDNESDAY MORNING. AT AROUND 6AM ON WEDNESDAY MORNING, THE CUSTOMER REPORTED THAT SHE WENT TO THE HOSPITAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253883 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO. LTD EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R ASTHMANEFRIN INHALATION SOLUTION