BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 3767608 · Received April 2, 2014

    Report

    Report Number
    3005442893-2014-00003
    Date Received
    April 2, 2014
    Report Date
    February 26, 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, HEALTH AND LIFE COMPANY 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. 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 THE PLATE A FELL FROM THE ATOMIZER TO THE BACK OF HER TONGUE; HOWEVER, THE PATIENT DID NOT SWALLOW THE COMPONENT. DURING A FOLLOW-UP PHONE CALL ON (B)(4), 2014, THE PATIENT'S FRIEND REPORTED THAT SHE OBSERVED THE EVENT WHEN THE PLATE A FELL INTO THE PATIENT'S MOUTH; HOWEVER, THE REPORTER DID NOT RECALL WHEN THE EVENT OCCURRED. THE REPORTER STATED THAT THE PATIENT RETRIEVED THE WASHER FROM HER MOUTH WHILE REQUIRING ANY MEDICAL INTERVENTIONS. THE PATIENT IS A (B)(6) FEMALE WHO IS (B)(6) INCHES AND (B)(6) POUNDS. HER PAST MEDICAL HISTORY IS SIGNIFICANT FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE PATIENT CURRENTLY SMOKES, AND SHE CONTINUES TO USE THE OTHER EZ BREATHE ATOMIZERS WITH NO OCCURRENCES OF A SIMILAR NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200080 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120801

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other THIS INFORMATION IS UNKNOWN