BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEA-BOND

    MDR report key: 1908924 · Received November 20, 2010

    Report

    Report Number
    MW5018295
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 20, 2010
    Manufacturer
    COMBE INC.
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTED USING SEA-BOND DENTURE ADHESIVE WAFERS IN MY TOP PLATE, AFTER 2 TO 3 DAYS MY MOUTH AND TONGUE BECAME IRRITATED, AND MY TONGUE BROKE OUT IN SEVERE BLISTERS, HAD TO SEE DOCTOR FOR MEDICATION. AT PRESENT TIME PROBLEM STILL EXISTS. DOSE OR AMOUNT: ONE WAFER. FREQUENCY: ONE DAILY. DIAGNOSIS OR REASON FOR USE: LOSE DENTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEA-BOND DENTURE ADHESIVE WAFERS KOL COMBE INC. R10G118

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR