BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3397201 · Received October 7, 2013

    Report

    Report Number
    1054871-2013-00075
    Event Type
    Injury
    Date Received
    October 7, 2013
    Date of Event
    August 28, 2013
    Report Date
    September 30, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO. LTD
    Product Code
    CCQ
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH EZ BREATHE ATOMIZER ON (B)(6) 2013. THE PT REPORTED THAT THE ATOMIZER DID NOT PRODUCE AN AEROSOL MIST TO ALLEVIATE HER RESPIRATORY DISTRESS. AFTER ADDING THAT SHE DID NOT CLEAN THE ATOMIZER PROPERLY, THE PT REPORTED THAT SHE REQUIRED MEDICAL TREATMENT AT THE HOSPITAL FOLLOWING THE ATOMIZER'S MALFUNCTION. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE UNSUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507132 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO. LTD EZ-100 121202

    Patients

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