BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALADON 65

    MDR report key: 6137752 · Received December 1, 2016

    Report

    Report Number
    9610902-2016-00019
    Event Type
    Injury
    Date Received
    December 1, 2016
    Report Date
    November 4, 2016
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBI
    PMA / PMN Number
    K902115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT OCCURRED IN (B)(6). FROM DIRECTIONS FOR USE: ADVICE: PRODUCT CONTAINS MONOMERS (E.G. METHACRYLATES) WHICH MAY CAUSE SKIN ALLERGIES, ESPECIALLY WITH SENSITIVE PATIENTS. FOR PATIENTS WITH A RESIN ALLERGY OR WHEN ALLERGIC REACTIONS ARE OBSERVED, THE PRODUCT IS CONTRAINDICATED. 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: DEVICE HAS NOT BEEN RETURNED BY CUSTOMER. LOT NUMBER UNKNOWN, NO RETURN.

    Description of Event or Problem · 0

    PATIENT HAS A MUSCOSAL INTOLERANCE AFTER GETTING A PROSTHESIS MADE OF PALADON 65.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788918 PALADON 65 RESIN, DENTURE, RELINING, REPAIRING, REBASING EBI HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other