BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS COMPOSITE

    MDR report key: 3447130 · Received October 1, 2013

    Report

    Report Number
    9610902-2013-00101
    Event Type
    Injury
    Date Received
    October 1, 2013
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION
    Product Code
    EBF
    PMA / PMN Number
    K020131
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH 608, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND DOCUMENTED. THE DIRECTIONS FOR USE STATES, "DO NOT USE VENUS IN PATIENTS, WHICH ARE ALLERGIC AGAINST THE INGREDIENTS OF VENUS."

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495602 VENUS COMPOSITE EBF, MATERIAL, TOOTH SHADE, RESIN EBF HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1