EFFERDENT OVERNIGHT WHITENING
Received Sep 10, 2021
Report 1719513-2021-01161 · MDR key 12453412
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Cancer
- Cancer
Narrative
Description of Event or Problem
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.