BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3027644 · Received March 28, 2013

    Report

    Report Number
    1054871-2013-00012
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 22, 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 CORPORATION VIA TELEPHONE REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. HE REPORTED THAT A SILVER PIECE FELL INTO HIS MOUTH WHILE USING THE EZ BREATHE ATOMIZER. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER VIA TELEPHONE AND MAIL TO CONFIRM THE REPORTED INCIDENT; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128154 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK THIS INFO.| NPC WAS UNABLE TO CONTACT THE PATIENT TO OBTAIN