BEUDAMED
    FDA Adverse Event Other Summary report: N

    LYNAL

    MDR report key: 518968 · Received April 2, 2004

    Report

    Report Number
    2515379-2004-00169
    Event Type
    Other
    Date Received
    April 2, 2004
    Date of Event
    March 3, 2004
    Report Date
    March 4, 2004
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT A PT EXPERIENCED A POSSIBLE ALLERGIC REACTION. THE PT HAS RED AND WHITE INFLAMMATION IN THE MAXILLARY ARCH. THE DOCTOR HAD THE PT RINSE THE AREA WITH WATER AND WASH WITH MILD SOAP AND DISCONTINUE USE OF DENTURE UNTIL HEALED. THE PT WAS ALSO ADVISED TO SEEK MEDICAL ATTENTION IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYNAL DENTURE RELINING, REPAIRING OR REBASING MATERIAL EBI DENTSPLY CAULK NA 030210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other EFFERDENT, DENTURES.