BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALAXPRESS, PINK, 1000G POWDER

    MDR report key: 5408240 · Received February 3, 2016

    Report

    Report Number
    9610902-2016-00003
    Event Type
    Injury
    Date Received
    February 3, 2016
    Report Date
    January 8, 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 HEALTH CARE PROFESSIONAL

    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 FOR METHOD/RESULTS/CONCLUSION CODES, DEVICE HAS NOT BEEN RETURNED BY CUSTOMER, LOT NUMBER NOT PROVIDED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE OCCURRED IN (B)(6). LAB REPORTS THREE PATIENTS EXPERIENCING MUCOSAL REDNESS AFTER PROSTHETIC TREAMENT WITH PALAXPRESS. THE LAB TECHNICIANS DO NOT MEASURE, BUT MIX FREEHAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64535 PALAXPRESS, PINK, 1000G POWDER RESIN, DENTURE, RELINING, REPAIRING, REBASING EBI HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other