BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3170013 · Received June 7, 2013

    Report

    Report Number
    3005442893-2013-00026
    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
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL 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 CONSEQUENCE IS IMPROBABLE AND THAT NO COMPLAINTS DOCUMENTING DEATHS OR SERIOUS INJURIES HAVE BEEN REC'D. HERE WITH THE INVESTIGATION REPORT AS ATTACHMENT, AND THE COMPLAINED DEVICE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION, THEREFORE, THE ROOT CAUSE CANNOT BE IDENTIFIED.

    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
    253558 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| O ASTHMANEFRIN INHALATION SOLUTION