BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALAXTREME, R50 GEADERT

    MDR report key: 10690383 · Received October 16, 2020

    Report

    Report Number
    3005665377-2020-00003
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 28, 2020
    Manufacturer
    KULZER GMBH - HQ
    Product Code
    EBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SALES OFFICE IN THE NETHERLANDS GOT AWARE OF A (B)(6) COMMUNICATION ABOUT SKIN IRRITATION CAUSED PALAXTREME. THIS MATERIAL IS NOT SOLD IN THE USA. KULZER NORTH AMERICA DISTRIBUTES A COMPARABLE PRODUCT, WHERE THE INDICATIONS OF USE ARE THE SAME, HOWEVER THE CHEMISTRY IS DIFFERENT. THE INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. 10/16/2020 DUE TO UP-DATE ISSUES OF ESUBMITTER AND WEBTRADER CLIENT THIS IS A LATE REPORTING AS MANUFACTURER. THE REPORT COULD NOT BE SUBMITTED EARLY DUE TO THE TECHNICAL ISSUES UNTIL FULLY UPDATE. THERE WAS NO DANGER TO OTHER PATIENTS OR A PUBLIC HEALTH THREAT DUE TO LATE REPORTING.

    Description of Event or Problem · 1

    ALLERGY SUSPICION. VIA (B)(6) WE BECAME AWARE OF AN ALLEGATION OF ALLERGY FOR PALAXTREME. 3 DENTAL TECHNICIANS AT 1 LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158562 PALAXTREME, R50 GEADERT RESIN, DENTURE, RELINING, REPAIRING, REBASING EBI KULZER GMBH - HQ K010021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other