BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVAPEN SNAP-ON CANNULAS REFILL

    MDR report key: 15824484 · Received November 18, 2022

    Report

    Report Number
    9612352-2022-00002
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    November 8, 2022
    Report Date
    November 18, 2022
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EID
    UDI-DI
    DVIV7457621
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS DUE TO THE LOOSE FIT OF THE CANNULAS, WHICH WERE CAUSED BY PRODUCTION ISSUES. APPROPRIATE QUALITY MEASURES & PRODUCTION CONTROLS WERE IMPLEMENTED TO CORRECT IRREGULARITIES. THE USERS OF THE AFFECTED DEVICES ARE BEING INFORMED OF THE RISK AND HOW TO MINIMIZE IT.

    Description of Event or Problem · 0

    A DOCTOR REPORTED THAT CANNULAS WERE FALLING INTO MULTIPLE PATIENTS MOUTH DUE TO FIT ISSUES. THE DOCTOR DID NOT INDICATE THAT ANY PATIENTS WERE INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231959 VIVAPEN SNAP-ON CANNULAS REFILL SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL EID IVOCLAR VIVADENT AG 745762 DVIV7457621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other