BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCO-GEL

    MDR report key: 2132198 · Received June 13, 2011

    Report

    Report Number
    2515379-2011-00010
    Event Type
    Injury
    Date Received
    June 13, 2011
    Report Date
    May 15, 2011
    Manufacturer
    DENTSPLY DETREY
    Product Code
    EBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE VISCO-GEL USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCE BEING DEPENDANT 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.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A PT EXPERIENCED A BURNING SENSATION AND HIS MOUTH "FELT ULCERATED" AFTER HAVING DENTURE RELINED WITH VISCO-GEL TISSUE CONDITIONING AND DENTURE RELINE MATERIAL. NO FURTHER MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCO-GEL EBI DENTSPLY DETREY 1003000265

    Patients

    Seq Age Sex Outcome Treatment
    1 Other