BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS DIAMOND FLOW SYR

    MDR report key: 3353264 · Received September 10, 2013

    Report

    Report Number
    1925223-2013-00131
    Event Type
    Injury
    Date Received
    September 10, 2013
    Report Date
    August 14, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THIS IS THE FIRST OF FOUR REPORTS FOR ONE OFFICE. SPOKE TO DENTAL ASSISTANT. SHE SAID THAT THEY NOTICED AIR BUBBLES WHILE EXTRUDING. SHE SAID THAT ABOUT FOUR PTS HAVE RETURNED DUE TO SENSITIVITY AND THEY REPLACED THE RESTORATIONS. TWO FOR THE SHADE A1 AND TWO FOR SHADE A2. SHE SAID THAT THE SENSITIVITY RESOLVED AND THEY ARE DOING FINE. SHE SAID THAT THEY CURE THE VDF FOR 20 SECONDS MINIMUM WITH AN LED CURING LIGHT. PLEASE REFER MFR REPORT # 9610902-2013-00094.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454496 VENUS DIAMOND FLOW SYR EBC SEALANT, PIT AND FISSURE, AND CONDI EBC HERAEUS KULZER GMBH A1 010105

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention