BEUDAMED
    FDA Adverse Event Other Summary report: N

    ILLUMINE

    MDR report key: 294834 · Received September 5, 2000

    Report

    Report Number
    2424472-2000-00005
    Event Type
    Other
    Date Received
    September 5, 2000
    Report Date
    August 29, 2000
    Manufacturer
    PREVENTIVE CARE DIVISION
    Product Code
    EJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A PT INFORMED A DENTIST THAT LATER IN THE EVENING FOLLOWING A TOOTH WHITENING DENTAL TREATMENT THAT HAD GONE TO THE HOSP BECAUSE OF THE PAIN IN THE TEETH AND OVERALL SWELLING AND IRRITATION THROUGHOUT THE GUMS, MOUTH AND THROAT. THE DENTIST ASKED THE PT TO RETURN TO HIS OFFICE SO THAT HE COULD DO A POST OPERATIVE EVAL. THE NEXT DAY AFTER THE POST OPERATIVE EVAL, THE DENTIST SAID THAT HE DID NOT NOTICE ANY SIGNS OF TISSUE TRAUMA WITH THE PT AND THAT THE TISSUE LOOKED IN GOOD HEALTH. HE WAS A LIITLE SKEPTICAL OF THE PT'S CLAIM OF EXTREME PAIN AFTER VIEWING OF THE ORAL ENVIRONMENT, BUT STILL PROCEEDED TO TREAT PT WITH A NEUTRAL SODIUM FLUORIDE GEL APPLICATION. THE PT WAS NO LONGER IN PAIN AND AGREED TO INFORM THE DENTIST IF ANY SYMPTOMS OF PAIN CAME BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMINE TOOTH WHITENER EJR PREVENTIVE CARE DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other