InjuryEMA
PROVICOL
Received May 29, 2026 · Event occurred Apr 13, 2026
Report 8010908-2026-00003 · MDR key 25327952
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Necrosis
- Pain
Narrative
Description of Event or Problem
A DENTIST CLAIMS THAT TREATMENT WITH PROVICOL LED TO LOCALISED, SUPERFICIAL AND, IN SOME CASES, PAINFUL TISSUE CHANGES IN SEVERAL PATIENTS. THE SYMPTOMS DESCRIBED INCLUDE A GREY DISCOLOURATION OF THE GUMS AND, IN SOME CASES, DETACHMENT OF THE MUCOUS MEMBRANE. THERE WAS NO MALFUNCTION. THE RESTORATIONS WERE REPLACED USING AN ALTERNATIVE MATERIAL. THE PATIENTS HAVE MADE A FULL RECOVERY. NO LASTING DAMAGE HAS OCCURRED.