BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARISMA

    MDR report key: 5599469 · Received April 22, 2016

    Report

    Report Number
    9610902-2016-00008
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    October 1, 2015
    Report Date
    April 7, 2016
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBI
    PMA / PMN Number
    K932013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION# E2012008, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER GMBH (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 METHOD/RESULTS/CONCLUSION- DEVICE HAS NOT BEEN RETURNED BY CUSTOMER. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    PATIENT REPORTS VAGUE AND DIFFUSE SYMPTOMS SINCE HAVING RESTORATIONS REPLACED WITH RESIN. ALLERGIST RECOMMENDED RESIN RESTORATIONS BE REPLACED WITH AMALGAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256045 CHARISMA MATERIAL, TOOTH SHADE, RESIN EBI HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention