BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3202301 · Received June 21, 2013

    Report

    Report Number
    3005442893-2013-00033
    Date Received
    June 21, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 21, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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 IN A MANNER LIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCES IS IMPROBABLE AND THAT NO COMPLAINTS DOCUMENTING DEATHS OR SERIOUS INJURIES HAVE BEEN RECEIVED. HEALTH AND LIFE, AS A MANUFACTURER, CONDUCTED A 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 APRIL 24 AND APRIL 30, 2013, RESPECTIVELY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE CUSTOMER REPORTED THAT HER HUSBAND USED THE EZ BREATHE ATOMIZER TO INHALE ASTHAMANEFRIN INHALATION SOLUTION. DURING ONE TREATMENT, SHE STATED THAT SHE SAW HER HUSBAND GAGGING AFTER INHALING FROM THE ATOMIZER. AFTER EXERTION, THE PATIENT WAS ABLE TO COUGH THE WASHER UP FROM HIS THROAT. THE PATIENT THEN OBTAINED A SECOND ATOMIZER TO USE, AND THE WASHER ALSO FELL OUT OF THIS ATOMIZER DURING USE. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION OR HOSPITALIZATION DURING THE COURSE OF THE INVESTIGATION. BOTH ATOMIZERS ARE BEING REPORTED SINCE THE INITIAL REPORTER WAS UNABLE TO DETERMINE THE SERIAL NUMBER OF THE ATOMIZER THAT WAS REPORTED AS CAUSING THE PATIENT TO GAG FROM THE LOOSE WASHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282060 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 121001

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR BEYOND ASTHMANEFRIN INHALATION SOLUTION.| THERE WERE NO CONCOMITANT MEDICAL PRODUCTS