BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3170015 · Received June 7, 2013

    Report

    Report Number
    3005442893-2013-00028
    Date Received
    June 7, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 7, 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 EVAL 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 REC'D. HEALTH AND LIFE, AS A MFR, CONDUCTED A PREVENTIVE 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 APR-24 AND APR-30 2013, RESPECTIVELY. HEREWITH THE INVESTIGATION REPORT AS ATTACHED.

    Description of Event or Problem · 1

    THE PT CONTACTED (B)(4) CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE CUSTOMER REPORTED THAT HE WAS USING THE EZ BREATHE ATOMIZER AT WORK WHEN A SMALL METAL WASHER WAS EJECTED INTO HIS MOUTH. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN MORE INFO CONCERNING THE INCIDENT; HOWEVER, NO INFO WAS READILY AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253484 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

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