BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS DIAMOND FLOW

    MDR report key: 3520741 · Received December 5, 2013

    Report

    Report Number
    1925223-2013-00168
    Event Type
    Injury
    Date Received
    December 5, 2013
    Report Date
    November 6, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS FOR ONE OFFICE USING TWO DIFFERENT DEVICES. A DENTIST PLACED ANTERIOR AND POSTERIOR FILLINGS AND THEY ALL CAME OUT A FEW WEEKS AFTER PLACEMENT. SHE USED IBOUND TE AND VENUS DIAMOND FLOW BXL. SHE ETCHED THE TEETH WITH H2PO 35% FOR 1 MIN, RINSED, LIGHTLY DRIED TO LEAVE SLIGHTLY MOIST. SHE APPLIED THE BONDING AGENT, AND IMMEDIATELY AIR DRIED WITH SHORT GENTLE AIR BLAST, AND THEN CURED FOR 20 SECONDS. DISCUSSED ALLOWING 15 SECONDS OF DWELL TIME AND CHECKING FOR UNIFORM GLOSSINESS. THE LOT NUMBER OF THE VENUS DIAMOND FLOW IS AN EXPIRED LOT NUMBER. SHE PLACED THESE FILLINGS IN OCTOBER AFTER IT HAD EXPIRED. DISCUSSED THAT EFFICACY IS NOT GUARANTEED AFTER THE EXPIRY DATE. SHE HAD TO GET BACK TO A PT SO SHE HAD TO GET OFF THE PHONE. PLEASE REFER MFR REPORT # 9610902-2013-00117.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630921 VENUS DIAMOND FLOW EBC SEALANT, PIT AND FISSURE, AND CONDI EBC HERAEUS KULZER GMBH BXL 010022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention