BEUDAMED
    FDA Adverse Event Other Summary report: N

    LYNAL

    MDR report key: 485259 · Received September 24, 2003

    Report

    Report Number
    2515379-2003-00142
    Event Type
    Other
    Date Received
    September 24, 2003
    Date of Event
    July 1, 2003
    Report Date
    August 25, 2003
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THEY EXPERIENCED BLISTERS ON THE TOP OF THEIR MOUTH AFTER CONTACT WITH LYNAL. AT THE TIME OF THIS REPORT THERE WAS NO FURTHER PT INFO AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other