BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 3422197 · Received October 11, 2013

    Report

    Report Number
    3005442893-2013-00075
    Date Received
    October 11, 2013
    Date of Event
    August 28, 2013
    Report Date
    September 30, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION 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. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE IDENTIFIED, SINCE THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE PT CONTACT NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATHE ATOMIZER ON (B)(6) 2013. THE PT REPORTED THAT THE ATOMIZER DID NOT PRODUCE AN AEROSOL MIST TO ALLEVIATE HER RESPIRATORY DISTRESS. AFTER ADDING THAT SHE DID NOT CLEAN THE ATOMIZER PROPERLY, THE PT REPORTED THAT SHE REQUIRED MEDICAL TREATMENT AT THE HOSPITAL FOLLOWING THE ATOMIZER'S MALFUNCTION. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE UNSUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521745 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 121202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O THIS INFORMATION WAS NOT IDENTIFIED DURING| THE INVESTIGATION.