MalfunctionEFW
TEPE IDB GREEN
Received Jun 18, 2026
Report 3003761382-2026-00003 · MDR key 25544175
Device
Generic name
Interdental Brush
Manufacturer
Tepe Munhygienprodukter AbCatalog 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.