BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3674924 · Received February 26, 2014

    Report

    Report Number
    1054871-2014-00002
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    HEALTH AND LIFE (SUZHOU) CO., LTD
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT 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 PT REPORTED THAT THE PLATE A FELL FROM THE ATOMIZER TO THE BACK OF HER TONGUE; HOWEVER, THE PT DID NOT SWALLOW THE COMPONENT. DURING A FOLLOW-UP PHONE CALL ON (B)(6) 2014, THE PT'S FRIEND REPORTED THAT SHE OBSERVED THE EVENT WHEN THE PLATE A FELL INTO THE PT'S MOUTH; HOWEVER, THE REPORTER DID NOT RECALL WHEN THE EVENT OCCURRED. THE REPORTER STATED THAT THE PT RETRIEVED THE WASHER FROM HER MOUTH WHILE REQUIRING ANY MEDICAL INTERVENTIONS. THE PT IS A (B)(6). HER PAST MEDICAL HISTORY IS SIGNIFICANT FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE PT 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
    117896 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH AND LIFE (SUZHOU) CO., LTD EZ-100 120801

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other