BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNAL TISSUE CONDITIONER AND TEMPORARY RELINER

    MDR report key: 3904182 · Received May 22, 2014

    Report

    Report Number
    2515379-2014-00030
    Event Type
    Injury
    Date Received
    May 22, 2014
    Report Date
    April 24, 2014
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBI
    PMA / PMN Number
    PRE-1976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO LYNAL DENTURE RELINING MATERIAL. THERE IS NO FURTHER INFORMATION TO INDICATE THE NATURE OF REACTION OR IF MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307028 LYNAL TISSUE CONDITIONER AND TEMPORARY RELINER RESIN, DENTURE, RELINING, REPAIRING, EBI DENTSPLY CAULK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other