BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIX TRAY ADHESIVE

    MDR report key: 888935 · Received August 3, 2007

    Report

    Report Number
    8010638-2007-00139
    Event Type
    Injury
    Date Received
    August 3, 2007
    Report Date
    July 12, 2007
    Manufacturer
    DENTSPLY DETREY-DEDENT
    Product Code
    EBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIRECTIONS FOR USE WARN THAT THE MATERIAL IS IRRITATING TO THE EYES, MUCOSA, AND SKIN AND ALSO THAT ALLERGIC REACTIONS MAY RESULT IN SUSCEPTIBLE INDIVIDUALS. WHILE ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDING UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL, THE SYMPTOMS REPORTED IN THIS CASE APPEAR TO BE MORE CONSISTENT WITH IRRITATION/BURNING RESULTING FROM CONTACT WITH THE SKIN/MUCOSA, RATHER THAN A SENSITIZATION REACTION. THE DIRECTIONS FOR USE ALSO INDICATE THAT THE TRAY ADHESIVE SHOULD BE USED WITH ALGINATE IMPRESSION MATERIALS ONLY; THE ADHESIVE WAS USED WITH A SILICONE MATERIAL INT HIS EVENT. HOWEVER, SINCE AN ANTIBIOTIC WAS ADMINISTERED IN THIS CASE, THE DEVICE WAS RETURNED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED BURNS ON THE MOUTH AND LIPS AFTER A PROCEDURE WAS PERFORMED USING AFFINIS SILICONE IMPRESSION MATERIAL SECURED TO THE TRAY USING FIX TRAY ADHESIVE; THE PATIENT WAS ADMINISTERED AN ANTIBIOTIC AND MOUTH RINSE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIX TRAY ADHESIVE EBH DENTSPLY DETREY-DEDENT NA 0605002849

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention AFFINIS SILICONE IMPRESSION MATERIAL