BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-BREATHE ATOMIZER

    MDR report key: 2824182 · Received November 2, 2012

    Report

    Report Number
    3005442893-2012-00003
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 2, 2012
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS AND RELEVANT FOLLOW-UP ACTIVITIES WILL BE INCLUDED IN 11/20/2012 FOLLOW-UP.

    Description of Event or Problem · 1

    HEALTH AND LIFE CO., LTD. WAS INFORMED BY THE (B)(4) WITH THE FOLLOWING INFO: THE PT PURCHASED THE MEDICATION FROM THE (B)(4) PHARMACY AFTER LEARNING OF AN OVER THE COUNTER PRODUCT THAT CONTAINS AN EPINEPHRINE INHALATION SOLUTION. AFTER THE INITIAL PRODUCT USE, SHE STATED THAT SHE JERKED AND TWITCHED. FURTHERMORE, SHE ALSO COUGHED UP A SMALL AMOUNT OF PINK PHLEGM, BUT SHE DID NOT REPORT THE INCIDENT SINCE SHE THOUGHT SHE WAS FINE. ON THE FOLLOWING NIGHT, SHE COUGHED UP PINK PHLEGM AGAIN AFTER USING THE MEDICATION. ON THE NEXT NIGHT, SHE EXPERIENCED JERKY SENSATION AND SWELLING OF HER THROAT AFTER USING THE PRODUCT. THE PT STATED THAT SHE USED ICE AND PRIMATENE MIST PRODUCT AT HOME TO ALLEVIATE THE SWELLING TEMPORARILY; HOWEVER, THE SWELLING RETURNED. THE PT THEN TRAVELED TO THE HOSPITAL EMERGENCY ROOM AND RECEIVED AN INJECTION OF EPINEPHRINE. THE EPINEPHRINE ALLEVIATED THE ANAPHYLACTIC RESPONSE, AND THE PT RETURNED HOME THAT SAME NIGHT WITH NO FURTHER PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HOME OXYGEN (DURATION UNK)