BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 4001804 · Received July 22, 2014

    Report

    Report Number
    3005442893-2014-00015
    Date Received
    July 22, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 20, 2014
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THIS FAILURE MODE FROM THE DESIGN FAILURE MODES AND EFFECTS ANALYSIS OF THIS PRODUCT, THAT THE USE OF THE PRODUCT IS A MANNER LIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCE IS IMPROBABLE. HEREWITH THE CLOSURE REPORT AS ATTACHMENT, THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE IDENTIFIED, SINCE THE DEVICE WAS CONFIRMED NOT RETURNED TO MANUFACTURER FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    NEPHRON PHARMACEUTICALS CORPORATION RECEIVED A PRODUCT COMPLAINT OF A LOOSE WASHER MALFUNCTION ON (B)(6) 2014, THAT WAS REPORTED AS ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT USED THE DEVICE TO ADMINISTER ASTHMANEFRIN (RACEPINEPHRINE INHALATION SOLUTION, 2.25%) TO ALLEVIATE HIS ASTHMA SYMPTOMS. DURING A FOLLOW-UP CALL ON (B)(6) 2014, THE INITIAL REPORTER STATED THAT SHE WAS SLEEPING AT THE TIME OF THE MALFUNCTION; HOWEVER, THE PATIENT LATER INFORMED THE REPORTER THAT HE FELT A FOREIGN OBJECT IN HIS MOUTH WHEN SHE AWOKE. THE PATIENT BRUSHED HIS TEETHED AND NOTICED THAT A SMALL WASHER WAS IN HIS MOUTH. HE WAS ABLE TO RETRIEVE THE COMPONENT WITHOUT REQUIRING ANY MEDICAL INTERVENTIONS. THERE WERE NO REPORTS OF ANY OCCURRENCES OF A SIMILAR NATURE ASSOCIATED WITH THE PATIENT'S USE OF THE DEVICE. THE PATIENT IS A (B)(6). HIS PAST MEDIAL HISTORY IS SIGNIFICANT FOR ASTHMA. ADDITIONAL INFORMATION CONCERNING THE PATIENT'S PAST MEDICAL HISTORY, MEDICATION REGIMEN, AND ALLERGIES ARE UNKNOWN. THE REPORTER ADDED THAT THE SUSPECTED DEVICE WAS PURCHASED IN (B)(6) 2013. THE INVESTIGATED PRODUCT FOR THE ENCLOSED MEDICAL DEVICE REPORT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MANUFACTURER HEALTH & LIFE, CO., LTD., ON (B)(6) 2013. THE CLASS 1 RECALL (Z-1371-2013, Z-1372-2013, Z-1373-2013) WAS INITIATED AFTER NEPHRON PHARMACEUTICALS CORPORATION, THE IMPORTER, BECAME AWARE OF AN INCREASING NUMBER OF COMPLAINTS ASSOCIATED WITH THE POSSIBILITY OF A QUARTER-INCH WASHER BECOMING DISLODGED FROM THE EZ BREATHE ATOMIZER. THE IMPACTED ATOMIZER SERIAL NUMBER RANGES ARE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427074 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120801

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other ASTHMANEFRIN (RACEPINEPHRINE INHALATION| SOLUTION, 2.25%)