BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONDIAL

    MDR report key: 6891932 · Received September 25, 2017

    Report

    Report Number
    3006610834-2017-00001
    Event Type
    Injury
    Date Received
    September 25, 2017
    Report Date
    September 7, 2017
    Manufacturer
    KULZER GMBH
    Product Code
    ELM
    PMA / PMN Number
    K060994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION #E2013019, KULZER, LLC (THE IMPORTER) IS REPORTING ON BEHALF OF KULZER, GMBH (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, THE INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    PATIENT COMPLAINS OF VAGUE ALLERGY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671460 MONDIAL DENTURE, PLASTIC, TEETH ELM KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other