BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS DIAMOND

    MDR report key: 5892835 · Received August 22, 2016

    Report

    Report Number
    9610902-2016-00015
    Event Type
    Injury
    Date Received
    August 22, 2016
    Report Date
    July 25, 2016
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBF
    PMA / PMN Number
    K073554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT COMES FROM (B)(6). 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. ON (B)(6) 2016 THE RESULTS OF THE ALLERGY TESTING (LTT) EXCLUDED VENUS DIAMOND AS CAUSING ALLERGEN. NOT RETURNED-NO LOT NUMBER.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT COMES FROM (B)(6). 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.

    Description of Event or Problem · 0

    THIS COMPLAINT COMES FROM (B)(6). PATIENT COMPLAINED OF MULTIPLE SYMPTOMS IN FACE AND JAW. FILLING MATERIAL HAS BEEN REPLACED WITH NO REDUCTION OF SYMPTOMS.

    Description of Event or Problem · 0

    THIS COMPLAINT COMES FROM (B)(6). PATIENT COMPLAINED OF MULTIPLE SYMPTOMS IN FACE AND JAW. FILLING MATERIAL HAS BEEN REPLACED WITH NO REDUCTION OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546712 VENUS DIAMOND MATERIAL, TOOTH SHADE, RESIN EBF HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 52 DA Required Intervention