BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALAXTREME, R50 VEINED, 1000G

    MDR report key: 10575048 · Received September 23, 2020

    Report

    Report Number
    1821514-2020-00004
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 23, 2020
    Manufacturer
    KULZER
    Product Code
    EBI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    10/14/2020- FOLLOW UP TO CORRECT ORIGINAL MANUFACTURER ENTERED. THIS INCIDENT IS REPORTABLE ACCORDING TO 21 CFR 803. THE FDA DEFINES THIS AS A SERIOUS INJURY (21 CFR SEC. 803.3) AS THE OFFICE STAFF REPORTED VIA FACEBOOK, KULZER BECAME AWARE OF AN ALLERGY CASE FOR PALAXTREME. 3 DENTAL TECHNICIANS AT 1 LABORATORY. THE EMPLOYEE HAVING AN ALLERGIC TYPE REACTION. 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.

    Description of Event or Problem · 0

    10/14/2020- FOLLOW UP TO CORRECT ORIGINAL MANUFACTURER ENTERED. ALLERGY SUSPICION. VIA FACEBOOK WE BECAME AWARE OF AN ALLERGY CASE FOR PALAXTREME. 3 DENTAL TECHNICIANS AT 1 LAB.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT IS REPORTABLE ACCORDING TO 21 CFR 803. THE FDA DEFINES THIS AS A SERIOUS INJURY (21 CFR SEC. 803.3) AS THE OFFICE STAFF REPORTED VIA (B)(6), KULZER BECAME AWARE OF AN ALLERGY CASE FOR PALAXTREME. 3 DENTAL TECHNICIANS AT 1 LABORATORY. THE EMPLOYEE HAVING AN ALLERGIC TYPE REACTION. 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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037002 PALAXTREME, R50 VEINED, 1000G RESIN, DENTURE, RELINING, REPAIRING, REBASING EBI KULZER K010021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other