BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS DIAMOND

    MDR report key: 6671757 · Received June 27, 2017

    Report

    Report Number
    9610902-2017-00009
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    March 7, 2016
    Report Date
    June 7, 2017
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBF
    PMA / PMN Number
    K073554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION# E2012008, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER GMBH (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. NARRATIVE-DEVICE HAS NOT BEEN RETURNED AND LOT NUMBER IS NOT KNOWN. ANALYSIS OF DIRECTIONS FOR USE STATE: THE USE OF THIS PRODUCT IS CONTRAINDICATED IN CASE OF KNOWN OR SUSPECTED ALLERGIES AGAINST (METH) ACRYLATE COMPOUNDS. H3 OTHER TEXT: NOT RETURNED, NO LOT NUMBER.

    Description of Event or Problem · 0

    MALE PATIENT HAS VAGUE ALLERGY SYMPTOMS SINCE HAVING DENTAL WORK DONE IN 2016. UNDERGOING ALLERGY TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450674 VENUS DIAMOND MATERIAL, TOOTH SHADE, RESIN EBF HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R