BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3150179 · Received June 4, 2013

    Report

    Report Number
    3005442893-2013-00023
    Date Received
    June 4, 2013
    Date of Event
    April 17, 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 DEATHS OR SERIOUS INJURIES HAVE BEEN RECEIVED. HEALTH AND LIFE, AS A MANUFACTURER, CONDUCTED A PREVENTATIVE ACTION AND CORRECTIVE ACTION TO ELIMINATE COMPLAINED DEVICE, 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 NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE PT REPORTED THAT A SILVER PIECE FELL FROM EZ BREATHE ATOMIZER INTO HIS MOUTH WHILE IN USE. HE ADDED THAT HE WAS COUGHING AND HAD TO PULL THE SILVER COMPONENT FROM THE BACK OF HIS THROAT IN ORDER TO REMOVE THE DEVICE COMPONENT. THE PT REPORTED THAT HE DIDN'T REQUIRE ANY MEDICAL INTERVENTIONS AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246696 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other THIS INFO WAS NOT IDENTIFIED DURING THE| INVESTIGATION