MalfunctionEFW
GUM TECHNIQUE DEEP CLEAN SOFT
Received Jun 8, 2026 · Event occurred May 12, 2026
Report 1413787-2026-00295 · MDR key 25428691
Device
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HI (B)(6). HOPE ALL IS WELL. I WAS JUST MADE AWARE THAT SEVERAL PATIENTS HAVE NOTIFIED OUR FRONT DESK STAFF THAT BRISTLES FROM THE TOOTHBRUSHES THEY HAVE BEEN USING HAVE COME OFF AND BECOME LODGED IN THEIR TEETH. IN ONE CASE IT GOT STUCK IN AN ELDERLY PATIENT¿S THROAT. PLEASE CHECK ON YOUR END IF THERE HAVE BEEN ANY CHANGES IN THE PRODUCTION OF THE TOOTHBRUSHES. JUST WANT TO PREVENT ANY FURTHER ISSUES FOR ANYONE. NO SERIOUS INJURIES HAVE BEEN REPORTED.
Additional Manufacturer Narrative
COMPLAINT NOT CONFIRMED.