BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIC DENTURE TEETH

    MDR report key: 3150529 · Received May 21, 2013

    Report

    Report Number
    9681707-2013-00005
    Event Type
    Injury
    Date Received
    May 21, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    ELM
    PMA / PMN Number
    K033628
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION #(B)(4), (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4) (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.

    Description of Event or Problem · 1

    IMP REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225435 ARTIC DENTURE TEETH ELM DENTURE, PLASTIC TEETH ELM HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1