inforMED
MalfunctionEFW

TEPE IDB GREEN

Received Jun 18, 2026

Report 3003761382-2026-00003 · MDR key 25544175

Device

Generic name

Interdental Brush

Catalog number

114062

Lot number

5070702

Product problems

  • Detachment of Device or Device Component

Patient

NA · Unknown

  • Pain

Narrative

Description of Event or Problem

DURING USE OF THE DEVICE, BRISTLES DETACHED FROM THE BRUSH HEAD, REPRESENTING A DEVICE MALFUNCTION. THE DETACHED BRISTLES BECAME LODGED IN THE CUSTOMER'S GUMS, CAUSING PAIN AND BLEEDING. THE CUSTOMER INDICATED THAT THE BRISTLES HAD NOT YET BEEN REMOVED AND THAT MEDICAL ASSISTANCE MIGHT BE REQUIRED. NO SERIOUS INJURY HAS BEEN CONFIRMED AT THE TIME OF REPORTING. HOWEVER, IF THE MALFUNCTION WERE TO RECUR, IT COULD RESULT IN A SERIOUS INJURY.