BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARBY DENTAL

    MDR report key: 12543795 · Received September 28, 2021

    Report

    Report Number
    2246990-2021-00001
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 22, 2021
    Report Date
    September 28, 2021
    Product Code
    EJI
    UDI-DI
    00889813037652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 0

    DENTIST WAS ADMINISTERING AN INFILTRATION INJECTION AND THE SYRINGE FELL APART DURING THE INJECTION CAUSING THE NEEDLE TO BECOME WEDGED IN THE PATIENT'S JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441686 DARBY DENTAL ASPIRATING SYRINGE CW TYPE EJI 9501595 0321 00889813037652

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other