BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATH ATOMIZER

    MDR report key: 3519918 · Received November 6, 2013

    Report

    Report Number
    3005442893-2013-00085
    Date Received
    November 6, 2013
    Date of Event
    September 25, 2013
    Report Date
    October 23, 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 CORRECTION 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. THE RECALL ACTION IS STILL ON THE PROCESS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATH ATOMIZER ON (B)(6) 2013. THE PATIENT REPORTED THAT THE WASHER FELL FROM THE ATOMIZER INTO HER MOUTH WHILE SHE WAS USING THE DEVICE. THE PATIENT WAS ABLE TO RETRIEVE THE COMPONENT WITHOUT REQUIRING ANY MEDICAL INTERVENTIONS. THE PATIENT REPORTED THAT SHE HAD THREE ATOMIZERS AT THE TIME OF THE EVENT AND DID NOT RECALL THE SOURCE OF THE WASHER; THEREFORE, THE NEPHRON REPRESENTATIVE WILL SUBMIT THREE MEDICAL DEVICE REPORTS FOR THE INVESTIGATION AT THIS TIME. THE PATIENT IS A (B)(6) FEMALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR A BRAIN ANEURYSM. SHE IS A CURRENT SMOKER AND ADDS THAT SHE DOES NOT HAVE ANY ALLERGIES TO MEDICATIONS OR ANY RESPIRATORY ILLNESSES. 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 08, 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572962 EZ BREATH ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR VALIUM| PAIN PILL| MUSCLE RELAXER| ASTHMANEFRIN INHALATION SOLUTION 2.25%| ANTIHYPERTENSIVE MEDICATION