BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 4962985 · Received July 31, 2015

    Report

    Report Number
    1054871-2015-00004
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 28, 2015
    Report Date
    July 31, 2015
    Manufacturer
    HEALTH AND LIFE (SUZHOU) CO., LTD
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE FOLLOW-UP PHONE CALL, THE PATIENT REPORTED THAT A WASHER-LIKE COMPONENT FELL FROM THE DEVICE; FURTHERMORE, THE PATIENT WAS ABLE TO RETRIEVE THE WASHER WITHOUT REQUIRING ANY MEDICAL INTERVENTIONS, AND HE DID NOT EXPERIENCE MEDICAL HARM. HE ADDED THAT THE WASHER EJECTED FROM THE MEDICATION CUP WHILE HE WAS INHALING THE RACEPINEPHRINE PRODUCT FROM THE MOUTHPIECE; HOWEVER, THE PATIENT'S ATOMIZER INSTRUCTIONS INDICATE THAT THE PATIENT SHOULD ONLY INHALE THE MIST EMITTED INTO THE AIR FROM THE ATOMIZER INSTEAD OF INHALING FROM THE MOUTHPIECE. THE PATIENT REPORTED THAT HE WILL RETURN THE DEVICE TO THE MANUFACTURER TO ASSIST IN THE INVESTIGATION. THE INVESTIGATED PRODUCT FOR THE ENCLOSED MEDICAL DEVICE REPORT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MANUFACTURER HEALTH AND LIFE, CO., LTD., ON MAY 8, 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).

    Description of Event or Problem · 1

    NEPHRON PHARMACEUTICALS CORPORATION RECEIVED A MALFUNCTION COMPLAINT OF A LOOSE WASHER ON (B)(6) 2015, THAT WAS REPORTED AS ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PATIENT REPORTED THAT A WASHER BECAME DISLODGED FROM THE DEVICE AND FELL IN HIS THROAT. DURING A FOLLOW-UP PHONE CALL ON (B)(6) 2015, THE PATIENT REPORTED THAT A SMALL WASHER SEPARATED FROM THE MEDICATION CUP AND FELL INTO HIS THROAT. HE ADDED THAT THE DEVICE FELL INTO HIS THROAT WHILE HE WAS INHALING ASTHMANEFRIN INHALATION SOLUTION, 2.25% FROM THE DEVICE; HOWEVER, THE PATIENT WAS ABLE TO RETRIEVE THE LOOSE WASHER. HE STATED THAT HE WAS BREATHING THE MEDICATION THROUGH THE DEVICE'S MOUTHPIECE WHEN THE MALFUNCTION OCCURRED; MOREOVER, HE WAS USING THE DEVICE TO TREAT A MILD ASTHMA EXACERBATION. THE PATIENT HAS USED THE DEVICE INTERMITTENTLY FOR AT LEAST 1.5-2 YEARS; HOWEVER, HE DID NOT USE THE DEVICE FOR A FEW MONTHS BEFORE USING THE DEVICE ON (B)(6) 2015. THE PATIENT IS A (B)(6) YEAR OLD MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. HE IS A FORMER SMOKER AND REPORTED THAT HE EXPERIENCES AN UPSET STOMACH WHEN HE USED FELDENCE (PIROXICAM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499006 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH AND LIFE (SUZHOU) CO., LTD EZ-100 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR RACEPINEPHRINE INHALATION SOLUTION, 2.25%| ASTHMANEFRIN INHALATION SOLUTION, 2.25%