BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALAXPRESS

    MDR report key: 8826025 · Received July 25, 2019

    Report

    Report Number
    3011203516-2019-00002
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    June 16, 2019
    Report Date
    July 25, 2019
    Manufacturer
    KULZER GMBH - HQ
    Product Code
    EBI
    PMA / PMN Number
    K902115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SYMPTOMS RESOLVED ONCE THE PATIENT DISCONTINUED THE USE OF THE PROSTHESIS. DUE TO THE FACT THAT AN ALLERGY TEST WILL NOT BE CONDUCTED AND IT HAS BEEN CONFIRMED THAT THE TECHNICIAN FOLLOWED THE DFU FOR THIS MATERIAL, WE CANNOT RULE OUT THAT OUR PRODUCT CAUSED, OR CONTRIBUTED TO THE PATIENT'S ALLERGIC TYPE REACTION. WE DO STATE IN OUR DFU THAT, "IF THE PATIENT IS ALLERGIC TO ONE OR MORE INGREDIENTS OF PALAXPRESS, THE PRODUCT MUST NOT BE USED". ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE. IT IS THE DENTAL PROFESSIONAL'S RESPONSIBILITY TO AVOID ALLERGIC REACTION BY DETAILED ANAMNESIS BEFORE THE TREATMENT. EVEN THAN IT CANNOT BE EXCLUDED IN TOTAL. KULZER (B)(4) BECAME AWARE OF THE EVENT FROM KULZER (B)(4) AND THEY SAW NO NECESSITY TO REPORT TO THEIR NCA. KULZER (B)(4) CONTACTED KULZER LLC NORTH AMERICA. KULZER NORTH AMERICA DECIDED TO REPORT THIS EVENT AS AN INCIDENT OUT OF CAUTION TO BE COMPLIANT WITH 21 CFR 803 AND OUT OF ABUNDANCE OF CAUTION. KULZER LLC DID NOT NOTIFY THE MANUFACTURER IN TIME ABOUT THEIR DECISION AND REPORT. THEREFORE, KULZER (B)(4) AS MANUFACTURER REPORTS THIS INCIDENT LATER THAN 30 DAYS.

    Description of Event or Problem · 1

    THE DENTAL TECHNICIAN MADE THE DENTURE AND IMMERSE IT IN WATER FOR OVER 12 HOURS IN ACCORDANCE WITH THE CURRENT IFU. THE PATIENT'S TONGUE BECAME SWOLLEN AFTER USING THE FULL DENTURE MADE OF PALAXPRESS. THE PATIENT HAS UNCOMFORTABLE BREATHING. RESOLUTION OF THE SYMPTOM WAS NOTED AFTER STOPPING THE USE OF THE DENTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619787 PALAXPRESS DENTURE BASE MATERIAL EBI KULZER GMBH - HQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other