BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3071292 · Received April 22, 2013

    Report

    Report Number
    1054871-2013-00017
    Event Type
    Malfunction
    Date Received
    April 22, 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
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON 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 THE MOUTH. THE PT THEN PURCHASED A SECOND EZ BREATHE ATOMIZER, THE WASHER FELL INTO HIS MOUTH. THE PT 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 PT REPORTED THAT HE DID NOT SUFFER ANY HARM OR REQUIRE ANY MEDICAL INTERVENTIONS AT THIS TIME. SINCE THE COMPLAINT INVOLVES TWO ATOMIZERS, TWO MDR REPORTS WILL BE FILED CITING THE SAME PT AND INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171952 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO. LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other UNIDENTIFIED