BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3222445 · Received July 5, 2013

    Report

    Report Number
    3005442893-2013-00039
    Date Received
    July 5, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 3, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 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 ASSOCIATED WITH THE EZ BREATHE ATOMIZER ON (B)(6) 2013. THE CUSTOMER REPORTED THAT THE WASHER FROM THE EZ BREATHE ATOMIZER FELL ON HIS GIRLFRIEND'S MOUTH WHILE SHE WAS USING THE DEVICE WITH ASTHMANEFRIN INHALATION SOLUTION. THE PATIENT REQUIRED NO ADDITIONAL MEDICAL INTERVENTION TO RECOVER THE DEVICE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308249 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120801

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other ASTHMANEFRIN INHALATION SOLUTION