BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALAXPRESS

    MDR report key: 8795390 · Received July 16, 2019

    Report

    Report Number
    1821514-2019-00008
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    June 18, 2019
    Report Date
    July 16, 2019
    Manufacturer
    KULZER GMBH
    Product Code
    EBI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KULZER LLC DID NOT NOTIFY THE MANUFACTURER. IN THIS INSTANCE, KULZER (B)(4), BECAME AWARE OF THE INCIDENT FIRST, AND CONTACTED KULZER, LLC IN NORTH AMERICA. 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".

    Description of Event or Problem · 1

    SWOLLEN TONGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589597 PALAXPRESS DENTURE ACRYLIC EBI KULZER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other