BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3472534 · Received November 6, 2013

    Report

    Report Number
    3005442893-2013-00076
    Date Received
    November 6, 2013
    Date of Event
    September 6, 2013
    Report Date
    October 3, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND CONTACTED NEPHRON PHARMACEUTICALS CORP REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATHE ATOMIZER ON (B)(6) 2013. HE REPORTED THAT HIS WIFE USED THE ATOMIZER IMMEDIATELY AFTER REMOVING THE DEVICE FROM THE BOX TO ALLEVIATE HER ASTHMA SYMPTOMS. HE ADDED THAT THE DEVICE DID NOT PRODUCE AN AEROSOL MIST TO ALLEVIATE HER ASTHMA SYMPTOMS, AND HIS WIFE REQUIRED MEDICAL TREATMENT AT THE HOSPITAL FOR THE ASTHMA ATTACK. THE PT'S PAST MEDICAL HISTORY IS SIGNIFICANT FOR ASTHMA. DURING THE FOLLOW-UP PHONE CALL, THE PT'S HUSBAND REPORTED THAT SHE REQUIRED MEDICAL TREATMENT PREVIOUSLY FOR ASTHMA AFTER ANOTHER ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST. AS A RESULT, TWO MEDICAL DEVICE REPORT MEDWATCH 3500A FORMS WILL BE SUBMITTED TO THE FDA AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571830 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 130101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O ASTHMANEFRIN INHALATION SOLUTION, 2.25%