BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3150200 · Received June 4, 2013

    Report

    Report Number
    3005442893-2013-00027
    Date Received
    June 4, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 30, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION 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 AND THAT NO COMPLAINTS DOCUMENTING DEATH OR SERIOUS INJURIES HAVE BEEN RECEIVED. HEALTH AND LIFE, AS A MANUFACTURER, CONDUCTED A PREVENTATIVE ACTION AND CORRECTIVE ACTION TO ELIMINATE THE ROOT CAUSE AND RECURRENCE. FURTHERMORE, FOR THE COMPLAINED DEVICE, HEALTH AND LIFE HAS INITIATED VOLUNTARY RECALL, AND THE RECALL NOTIFICATION LETTER AND REQUIRED RECALL MATERIALS WERE ISSUED AND SUBMITTED ON 04/24 AND 04/30/2013, RESPECTIVELY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED (B)(4) CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE PT REPORTED THAT THE WASHER FELL FROM THE EZ BREATHE ATOMIZER INTO HER MOUTH DURING USE. SHE ADDED THAT SHE BEGAN TO COUGH AND ULTIMATELY VOMITED BEFORE THE DEVICE COMPONENT WAS REMOVED FROM HER THROAT. SHE ALSO REPORTED THAT THE DEVICE COMPONENT SCRATCHED HER THROAT WHEN SHE VOMITED THE PRODUCT. THE PT REPORTED THAT HE DIDN'T REQUIRE ANY MEDICAL ATTENTION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246799 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other THIS INFORMATION WAS NOT IDENTIFIED DURING THE| INVESTIGATION.