BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 3817727 · Received April 23, 2014

    Report

    Report Number
    3005442893-2014-00007
    Date Received
    April 23, 2014
    Report Date
    March 19, 2014
    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

    THE ROOT CAUSE OF THIS EVENT CANNOT BE IDENTIFIED, SINCE THE UNIT WAS NEVER RETURNED TO MANUFACTURER FOR FURTHER ANALYSIS. HOWEVER, THE PRELIMINARY EVALUATE RESULT IS DETERMINED TO BE SIMILAR TO THE EVENT OF THE MDR 3005442893-2013-00003, BASED ON THE LIMITED INFORMATION. WITH REGARD TO THE KNOWN POSSIBLE CAUSE, (B)(6) HAVE BEEN TAKING PREVENTATIVE ACTION AND CORRECTIVE ACTION TO ELIMINATE THE ROOT CAUSE AND RECURRENCE. FURTHERMORE, FOR THE COMPLAINED DEVICES, HEALTH AND LIFE HAS INITIATED VOLUNTARY RECALL, AND THE RECALL NOTIFICATION LETTER AND REQUIRED RECALL MATERIALS WERE ISSUED AND SUBMITTED ON APRIL 24 AND APRIL 30, 2013, RESPECTIVELY. THE RECALL ACTION IS STILL ON THE PROCESS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED NEPHRON PHARMACEUTICALS CORP. VIA TELEPHONE ON (B)(6) 2014, REGARDING A PRODUCT COMPLAINT OF LOOSE WASHER THAT WAS REPORTED AS ASSOCIATED WITH THE MALFUNCTION OF THE EZ BREATHE ATOMIZER. THE PATIENT REPORTED THAT A LOOSE WASHER FELL FROM THE MEDICATION CUP INTO HER MOUTH WHILE USING THE DEVICE. DURING A FOLLOW-UP PHONE CALL ON (B)(6) 2014, THE PATIENT REPORTED THAT THE MALFUNCTION OCCURRED DURING THE FINAL QUARTER OF 2013. SHE ADDED THAT SHE RECOVERED THE ATOMIZER COMPONENT WITHOUT REQUIRING ANY MEDICAL INTERVENTION. THE PATIENT IS A (B)(6) FEMALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. SHE IS A FORMER CIGARETTE AND MARIJUANA SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245052 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other