BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3131561 · Received May 17, 2013

    Report

    Report Number
    3005442893-2013-00016
    Date Received
    May 17, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 16, 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 CONTACTED NEPHROM PHARMACEUTICALS CORP. REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE COMPLAINANT REPORTED THAT A WASHER FELL FROM THE EZ BREATHE ATOMIZER INTO HIS MOUTH; HOWEVER, HE RETRIEVED THE WASHER FROM HIS MOUTH. THE PATIENT THEN PURCHASED A SECOND EZ BREATHE ATOMIZER FROM THE STORE. WHILE USING THIS EZ BREATHE ATOMIZER, THE WASHER FELL INTO HIS MOUTH. THE PATIENT REPORTED THAT HE SWALLOWED THE WASHER. THE CUSTOMER THEN REPORTED THAT HE SAW THE WASHER IN HIS STOOL DURING THE NEXT DAY. AFTER CONTACTING THE CUSTOMER, THE PATIENT REPORTED THAT HE DID NOT SUFFER ANY HARM OR REQUIRE ANY MEDICAL INTERVENTIONS AT THIS TIME. SINCE THIS COMPLAINT INVOLVES TWO ATOMIZERS, TWO MDR REPORTS WILL BE FILED CITING THE SAME PATIENT AND INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220174 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other UNIDENTIFIED