BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERDENT OVERNIGHT WHITENING

    MDR report key: 12453412 · Received September 10, 2021

    Report

    Report Number
    1719513-2021-01161
    Event Type
    Injury
    Date Received
    September 10, 2021
    Report Date
    September 10, 2021
    Product Code
    EGT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL ((B)(6) 2021): THIS SERIOUS CASE REPORTED VIA E-MAIL REFERS TO A MALE CONSUMER WHOSE AGE, MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND ALLERGIES WERE NOT REPORTED. ON AN UNREPORTED DATE, CONSUMER REPORTED USING EFFERDENT OVERNIGHT WHITENING TABLETS TO CLEAN HIS DENTURES AND DEVELOPED "HOT SPOTS" ON HIS GUMS WHICH LATER DEVELOPED INTO INFECTION. THE CONSUMER SOUGHT MEDICAL ATTENTION FROM AN ORAL SURGEON. A BIOPSY OF THE GUMS REVEALED ORAL CANCER. THE COMPANY ATTEMPTED TO OBTAIN SPECIFIC PRODUCT USE INFORMATION AND MEDICAL RECORDS, HOWEVER, THE CONSUMER REFUSED TO OFFER THIS INFORMATION. THIS CASE OUTCOME IS NOT RECOVERED/RESOLVED. MEDDRA VERSION (B)(4): EXPECTEDNESS: LIP AND/OR ORAL CAVITY CANCER: UNEXPECTED. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352628 EFFERDENT OVERNIGHT WHITENING DENTURE CLEANSER EGT NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other