BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3150197 · Received June 4, 2013

    Report

    Report Number
    3005442893-2013-00025
    Date Received
    June 4, 2013
    Date of Event
    April 22, 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 IS A MANNER LIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCE IS IMPROBABLE AND THAT NO COMPLAINTS DOCUMENTING DEATHS 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 DEVICES, HEALTH AND LIFE HAS INITIATED VOLUNTARY RECALL, AND THE RECALL NOTIFICATION LETTER AND REQUIRED RECALL MATERIALS WERE ISSUED AND SUBMITTED ON (B)(4) 2013, RESPECTIVELY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED (B)(4) CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(4) 2013. THE PT REPORTED THAT A SILVER PIECE FELL FROM EZ BREATHE ATOMIZER INTO HIS MOUTH WHILE IN USE. HE ADDED THAT HE SAW BROKEN PIECES OF THE WASHER ON THE GROUND AND BELIEVED THAT HE SWALLOWED THE BROKEN PORTIONS OF THE WASHER IN HIS MOUTH. THE PT REPORTED THAT HE DIDN'T REQUIRE MEDICAL ATTENTION FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246753 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR THIS INFORMATION WAS NOT IDENTIFIED DURING THE| INVESTIGATION