BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E2 BREATHE ATOMIZER

    MDR report key: 3111651 · Received May 13, 2013

    Report

    Report Number
    MW5030127
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 13, 2013
    Manufacturer
    NEPHRON PHARMACEUTICALS CORP
    Product Code
    CCQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR REPORTS THAT WHILE USING THE DEVICE, A SMALL DISC ACTUALLY POPPED-OUT AND ROLLED INTO THE BACK OF HIS MOUTH, STRAIGHT INTO HIS THROAT. THIS HAS A SERIOUS CHOKING RISK. HE HAD TO CAREFULLY REACH DOWN INTO HIS MOUTH TO RETRACT THE PIECE BEFORE HE ASPIRATED. ALSO THE DEVICE RELEASED THE MEDICATION WHICH POURED ONTO HIS TONGUE AND CAUSED BLISTERS AND PAIN. HE REPORTED THIS TO THE COMPANY BEFORE THE DEVICE WAS LATER RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209792 E2 BREATHE ATOMIZER ATOMIZER CCQ NEPHRON PHARMACEUTICALS CORP E2-100

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening