BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3458013 · Received October 3, 2013

    Report

    Report Number
    1054871-2013-00077
    Event Type
    Injury
    Date Received
    October 3, 2013
    Date of Event
    September 6, 2013
    Report Date
    October 3, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THERE EZ BREATHE ATOMIZER ON (B)(6) 2013. HE REPORTED THAT HIS WIFE USED THE ATOMIZER IMMEDIATELY AFTER REMOVING THE DEVICE FROM THE BOX TO ALLEVIATE HER ASTHMA SYMPTOMS. HE ADDED THAT THE DEVICE DID NOT PRODUCE AN AEROSOL MIST TO ALLEVIATE HER ASTHMA SYMPTOMS, AND HIS WIFE REQUIRED MEDICAL TREATMENT AT THE HOSPITAL FOR HER ASTHMA ATTACK. THE PATIENT'S PAST MEDICAL HISTORY IS SIGNIFICANT FOR ASTHMA. DURING THE FOLLOW-UP PHONE CALL, THE PATIENT'S HUSBAND REPORTED THAT SHE REQUIRED MEDICAL TREATMENT PREVIOUSLY FOR ASTHMA AFTER ANOTHER ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST. AS A RESULT , TWO MEDIAL DEVICE REPORT MEDWATCH 3005A FORMS WILL BE SUBMITTED TO THE FDA AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499925 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O ASTHMANEFRIN INHALATION SOLUTIONS, 2.25%| (UNIDENTIFIED DURATION)