BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVO NOVIL P SOFT FAST

    MDR report key: 6536625 · Received May 2, 2017

    Report

    Report Number
    3011203516-2017-00001
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    March 29, 2017
    Report Date
    April 3, 2017
    Manufacturer
    HERAEUS KULZER SRL
    Product Code
    ELW
    PMA / PMN Number
    K973694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION # E2015010, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER SRL (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 FOR SECTION H6 METHOD, RESULTS AND CONCLUSIONS CODES THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    34 YEAR OLD MALE PATIENT HAD ITCHING AND BURNING SENSATION IN MOUTH AFTER USE OF PROVO NOVIL. HAS HISTORY OF ALLERGIC REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319495 PROVO NOVIL P SOFT FAST MATERIAL, IMPRESSION ELW HERAEUS KULZER SRL R010039

    Patients

    Seq Age Sex Outcome Treatment
    1 34 Other