BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENUS COMPOSITE

    MDR report key: 3571828 · Received December 23, 2013

    Report

    Report Number
    1925223-2013-00178
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Report Date
    December 2, 2013
    Manufacturer
    HERAES KULZER GMBH
    Product Code
    EBF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS FOR TWO DEVICES FROM THE SAME OFFICE. A DENTIST IN (B)(6) COMPLAINED THAT THE COMPOSITE DID NOT CURE. MFR REF # 9160902-2013-00120.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672484 VENUS COMPOSITE EBF MATERIAL, TOOTH SHADE, RESIN EBF HERAES KULZER GMBH OB2 010402

    Patients

    Seq Age Sex Outcome Treatment
    1