BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 4051812 · Received August 7, 2014

    Report

    Report Number
    1054871-2014-00015
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 13, 2014
    Report Date
    August 7, 2014
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADD'L INFO WAS AVAILABLE FROM THE PT CONCERNING THE NATURE OF THE MALFUNCTION; THEREFORE, NEPHRON IS UNABLE TO DETERMINE IF THE PT'S ATOMIZER WAS AMONG THE LOTS ASSOCIATED WITH A CLASS 1 RECALL OF THE ATOMIZER INITIATED IN 2013. THE RECALL WAS INITIATED IN RESPONSE TO THE DETACHMENT OF THE PLATE A FROM THE MEDICATION CUP. THE DETACHMENT OF THE PLATE A CAN CAUSE THE PLATE A WASHER TO FALL THROUGH THE MOUTHPIECE OR CAUSE THE ATOMIZER TO FAIL TO PRODUCE A MIST. IT IS UNK WHEN THE PT PURCHASED THE UNIT OR HOW LONG THE PT HAS USED THE UNIT; THEREFORE, NEPHRON CANNOT DETERMINE THE NATURE OF THE MALFUNCTION.

    Description of Event or Problem · 1

    NEPHRON PHARMACEUTICALS CORPORATION RECEIVED A REPORT OF A DEVICE MALFUNCTION ON (B)(6) 2014, ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PT REPORTED THAT HE EXPERIENCED A SEVERE ASTHMA ATTACK AFTER THE DEVICE DID NOT FUNCTION. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER BY TELEPHONE AND MAIL UNSUCCESSFULLY. NO ADD'L INFO IS AVAILABLE CONCERNING THE PT'S DEMOGRAPHICS OR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466292 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK