InjuryJES
DENTEK KIDS FUN FLOSSERS, 90 CT.
Received Oct 15, 2025
Report 1719513-2025-00021 · MDR key 23285248
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Female
- Tooth Fracture
- Tooth Fracture
Narrative
Description of Event or Problem
INITIAL (B)(6) 2025). THIS SERIOUS CASE REPORTED ON BAZAARVOICE REFERS TO A FEMALE CONSUMER OF UNKNOWN AGE WHO USED THE DENTEK FUN FLOSSERS FOR AN UNKNOWN INDICATION. ON AN UNREPORTED DATE, THE CONSUMER USED THE FLOSS AND REPORTED IT CAUSED SOME OF HER TOOTH TO BREAK OFF. IT IS UNKNOWN IF THE CHILD WAS SUPERVISED DURING USE. THIS CASE OUTCOME IS UNKNOWN. DUE TO THE PLATFORM THE COMPANY IS ONLY ABLE TO FOLLOW UP WITH A REPLY TO THE CONSUMER ONCE. MEDDRA VERSION 28.0 EXPECTEDNESS: TOOTH FRACTURE: UNEXPECTED. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.