BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXITME MONOPHASE

    MDR report key: 7872196 · Received September 13, 2018

    Report

    Report Number
    3011203516-2018-00003
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    August 17, 2018
    Report Date
    August 17, 2018
    Manufacturer
    KULZER, LLC
    Product Code
    ELW
    PMA / PMN Number
    K113574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS OCCURRED IN GERMANY. AS IS ALLOWED BY EXEMPTION # E2015010, KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF 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. THE RETURNED DEVICE HAS BEEN ANALYZED AND TESTS COMPLETELY WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    FEMALE PATIENT, 53 YEARS OLD TREATED WITHFLEXITIME MONOPHASE IMPRESSION MATERIAL. SHE DEVELOPED SWELLING AND REDNESS OF THE MUCOSA AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714374 FLEXITME MONOPHASE MATERIAL, IMPRESSION ELW KULZER, LLC R010069

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other