BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 3610854 · Received January 16, 2014

    Report

    Report Number
    3005442893-2013-00100
    Date Received
    January 16, 2014
    Date of Event
    November 18, 2013
    Report Date
    December 16, 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

    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 & LIFE COMPANY HAVE BEEN TAKING PREVENTATIVE ACTION AND CORRECTIVE ACTION TO ELIMINATE THE ROOT CAUSE AND RECURRENCE. FURTHER MORE, 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 APR-24 AND APR-30 2013, RESPECTIVELY. THE RECALL ACTION IS STILL IN PROCESS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT OF A LOOSE WASHER ON (B)(6) 2013, ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PATIENT REPORTED THAT A SILVER CIRCULAR RING FELL FROM THE ATOMIZER INTO HIS MOUTH WHILE USING THE PRODUCT. HE DID NOT EXPERIENCE ANY HARM. DURING A FOLLOW-UP PHONE CALL ON (B)(6) 2013, THE PATIENT REPORTED THAT THE WASHER ROLLED THROUGH THE MOUTH PIECE AND LANDED ON HIS TONGUE. THE MALFUNCTION WAS REPORTED DUE TO THE POTENTIAL COMPLICATIONS FROM THE INGESTION OF A FOREIGN. THE PATIENT IS A MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. NO OTHER INFORMATION CONCERNING CONCOMITANT DRUG THERAPY, ALLERGIES, SMOKING HISTORY AND DEMOGRAPHIC FACTORS WERE AVAILABLE. AN ADVERSE EVENT WAS NOT REPORTED IN ASSOCIATION WITH THIS PRODUCT COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42510 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other