BEUDAMED
    FDA Adverse Event Summary report: N

    EZ BREATHE ATOMIZER

    MDR report key: 3170011 · Received June 7, 2013

    Report

    Report Number
    3005442893-2013-00024
    Date Received
    June 7, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 7, 2013
    Manufacturer
    HEALTH & LIFE (SUZHOU) CO., LTD.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL 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 CONSEQUENCE IS IMPROBABLE AND THAT NO COMPLAINTS DOCUMENTING DEATHS OR SERIOUS INJURIES HAVE BEEN REC'D. HEALTH AND LIFE, AS A MFR, CONDUCTED A PREVENTIVE ACTION AND CORRECTIVE ACTION TO ELIMINATE THE ROOT CAUSE AND RECURRENCE. (B)(4).

    Description of Event or Problem · 1

    THE (B)(6) REP CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE REP REPORTED THAT A PT AT A (B)(6) RETURNED THE ASTHAMENFRIN INHALATION SOLUTION AND EZ BREATHE ATOMIZER FOR A REFUND AND ADDED THAT A METAL PART OF THE ATOMIZER SHOT INTO HIS MOUTH DURING THE USE OF THE EZ BREATHE ATOMIZER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN MORE INFO CONCERNING THE INCIDENT; HOWEVER, NO INFO WAS AVAILABLE CONCERNING THE PRODUCT SERIAL NUMBER OR THE PT INFO OTHER THAN THE PT'S SEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253725 EZ BREATHE ATOMIZER ATOMIZER CCQ HEALTH & LIFE (SUZHOU) CO., LTD. EZ-100 UNIDENTIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other THIS INFO WAS NOT IDENTIFIED DURING THE| INVESTIGATION