BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS DIAMOND

    MDR report key: 8451395 · Received March 26, 2019

    Report

    Report Number
    9610902-2019-00003
    Event Type
    Injury
    Date Received
    March 26, 2019
    Report Date
    March 20, 2019
    Manufacturer
    KULZER GMBH
    Product Code
    EBF
    PMA / PMN Number
    K910263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLERGY TESTING THAT WAS CONDUCTED, CONCLUDED THAT THE PATIENT TESTED NEGATIVE FOR (METH) ACRYLATE COMPOUND ALLERGIES. HOWEVER, THE TEST DID NOT INCLUDE TCD-DI-HEA. PER THE GLOBAL SAFETY MANAGER OF KULZER, IT IS VERY LIKELY THAT WITH THE PATIENT HAVING NEGATIVE REACTIONS TO THE AFORE MENTIONED (METH) ACRYLATES, THIS IS LIKELY ALSO TRUE FOR THE TCD-DI-HEA. HOWEVER LIKELY THIS MAY BE, IT CANNOT CONCRETELY RULE OUT THAT THE SYMPTOMS EXPERIENCED WERE NOT CAUSE BY THE VENUS DIAMOND COMPOSITE OR THE COMPOSITE MATERIAL DID NOT CONTRIBUTE TO THE PATIENT REACTION. THIS INCIDENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION AND TO MAINTAIN COMPLIANCE WITH 21 CFR 803. KULZER, LLC (IMPORTER) IS REPORTING THIS INCIDENT ON BEHALF OF KULZER GMBH (MANUFACTURER) UNDER THE EXEMPTION NUMBER E2013019. THIS INCIDENT OCCURRED IN SWEDEN.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED STRONG BURNING SENSATION IN THE MOUTH. SHE ALSO REPORTED DRYNESS OF THE MOUTH AND STATED THE USE OF ARTIFICIAL SALIVA PROVIDES RELIEF FROM THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244333 VENUS DIAMOND COMPOSITE RESIN EBF KULZER GMBH K010040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other