BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT CONTROL SYRINGE

    MDR report key: 472168 · Received July 10, 2003

    Report

    Report Number
    1419322-2003-00067
    Event Type
    Malfunction
    Date Received
    July 10, 2003
    Report Date
    April 28, 2003
    Manufacturer
    DENTSPLY PROFESSIONAL (MIDWEST)
    Product Code
    EJI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DR REPORTED THAT ABOUT HALF THE TIME THE UNITS ARE BEING USED, THE HARPOON IS NOT ENGAGING THE RUBBER STOPPER AND THEREFORE NOT ASPIRATING PROPERLY. TWO PATIENTS IN THE LAST YEAR HAVE HAD EPINEPHRINE ATTACKS AND WERE FINE AFTER A COUPLE OF MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORT CONTROL SYRINGE CARTRIDGE SYRINGE, DENTAL EJI DENTSPLY PROFESSIONAL (MIDWEST) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other