BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3113317 · Received April 12, 2013

    Report

    Report Number
    3005442893-2013-00010
    Date Received
    April 12, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 12, 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

    HEREWITH THE INVESTIGATION PLAN, THE INVESTIGATION RESULTS AND RELEVANT F/U ACTIVITIES WILL BE INCLUDED IN (B)(6) 2013 F/U.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORP REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE CUSTOMER REPORTED THAT SHE EXPERIENCED TWO PROBLEMS WITH TWO ATOMIZERS THAT SHE PURCHASED - THE MEDICATION CUP LATCH WOULD NOT REMAIN CLOSED, AND THE ATOMIZERS WOULD NOT PRODUCE AN AEROSOL TO DELIVER THE MEDICATION. SEVERAL ATTEMPTS VIA E-MAIL WERE MADE TO CONTACT THE CUSTOMER; HOWEVER, THE CUSTOMER ADVISED THAT NPC DISCONTINUE ALL FURTHER COMMUNICATION WITH HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159662 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

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