BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVAPEN SNAP-ON CANNULAS REFILL

    MDR report key: 15787527 · Received November 14, 2022

    Report

    Report Number
    9612352-2022-00001
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 8, 2022
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EID
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A DOCTOR REPORTED THAT CANNULAS WERE FALLING INTO PATIENTS MOUTH DUE TO FIT ISSUES AND THEY HAD TO SUCTION OR FINGER SWEEP THEM OUT OF THE MOUTH. THE DOCTOR STATED THAT NO PATIENTS WERE INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2839497 VIVAPEN SNAP-ON CANNULAS REFILL SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL EID IVOCLAR VIVADENT AG ZL0906

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other