BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3131586 · Received May 17, 2013

    Report

    Report Number
    3005442893-2013-00020
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 18, 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 THE ROOT CAUSE AND RECURRENCE. FURTHERMORE, FOR THE COMPLAINED DEVICES, HEALTH AND LIFE HAS INITIATED A CLASS II 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 ORIGINALLY CONTACTED NEPHRON PHARMACEUTICALS CORP. REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. IN HIS ABSENCE, THE PATIENT'S WIFE REPORTED THAT A WASHER FELL INTO HER HUSBAND'S MOUTH WHILE USING THE EX BREATHE ATOMIZER. THE CUSTOMER ADDED THAT HE WAS ABLE TO SUCCESSFULLY REMOVE THE COMPONENT FROM HIS MOUTH. THE PATIENT'S WIFE REPORTED THAT HE DID NOT EXPERIENCE ANY MEDICAL HARM OR REQUIRE ANY MEDICAL INTERVENTIONS FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219958 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other UNIDENTIFIED