BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 3551384 · Received December 23, 2013

    Report

    Report Number
    3005442893-2013-00092
    Date Received
    December 23, 2013
    Date of Event
    October 22, 2013
    Report Date
    November 20, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH AND LIFE COMPANY HAVE BEEN TAKING PREVENTATIVE ACTION AND CORRECTIVE ACTION TO ELIMINATE THE ROOT CAUSE AND RECURRENCE. FURTHERMORE, FOR THE COMPLAINED DEVICES, HEALTH AND LIFE HAS INITIATED VOLUNTARY RECALL, AND THE RECALL NOTIFICATION LETTER AND REQUIRED RECALL MATERIALS WERE ISSUED AND SUBMITTED ON (B)(4) 2013, RESPECTIVELY. THE RECALL ACTION IS STILL ON THE PROCESS.

    Description of Event or Problem · 1

    THE PT CONTACTED NEPHRON PHARMACEUTICALS CORP ON (B)(6) 2013, REGARDING A REPORTABLE PRODUCT COMPLAINT OF LOOSE WASHER ASSOCIATED WITH THE EZ BREATH ATOMIZER. THE PT REPORTED THAT SHE HAD THREE ATOMIZERS ASSOCIATED WITH THE COMPANY'S CLASS 1 RECALL THAT SHE PURCHASED WHEN THE ASTHMANEFRIN STARTER KIT WAS FIRST INTRODUCED. IN ADDITION, A WASHER FELL FROM ONE OF THE UNITS INTO THER THROAT; HOWEVER, SHE DOES NOT RECALL WHICH ATOMIZER WAS THE SOURCE OF HER COMPLAINT. DURING A F/U PHONE CALL ON (B)(6) 2013, SHE REPORTED THAT THE WASHER EJECTED FROM THE ATOMIZER INTO HER THROAT DURING THE INITIAL USE; HOWEVER, SHE ADDED THAT SHE WAS ABLE TO COUGH THE WASHER UP W/O REQUIRING ANY MEDICAL INTERVENTIONS. THE PT IS A (B)(6) FEMALE WHO REPORTED THAT HER PAST MEDICAL HISTORY IS SIGNIFICANT FOR ASTHMA ((B)(6)). AS STATED PREVIOUSLY, THE ATOMIZER UNDER INVESTIGATION WAS NOT IDENTIFIED; THEREFORE, ALL THREE UNITS WILL BE REPORTED TO THE AGENCY AS ASSOCIATED WITH THE PRODUCT COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672439 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other