BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3265973 · Received July 30, 2013

    Report

    Report Number
    3005442893-2013-00048
    Date Received
    July 30, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 2, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH & LIFE, AS A MANUFACTURER, CONDUCTED A PREVENTATIVE ACTION AND CORRECTIVE ACTION TO ELIMINATE THE ROOT CAUSE AND RECURRENCE. FURTHERMORE, FOR THE COMPLAINED DEVICES, HEALTH & LIFE HAS INITIATED VOLUNTARY RECALL, AND THE RECALL NOTIFICATION LETTER AND REQUIRED RECALL MATERIALS WERE ISSUED AND SUBMITTED ON (B)(4) AND (B)(4) 2013, RESPECTIVELY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(4) 2013. THE CUSTOMER REPORTED THAT A WASHER FELL FROM THE EZ BREATHE ATOMIZER INTO HIS MOUTH WHILE USING THE DEVICE. HE REPORTED THAT HE DID NOT REQUIRE ANY MEDICAL INTERVENTIONS TO RECOVER THE COMPONENT. THE PATIENT IS A (B)(6) YEAR OLD MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354925 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other NO OTHER PRODUCTS WERE REPORTED