InjuryLBH
VOCO PROFLUORID VARNISH
Received Dec 4, 2024 · Event occurred Nov 4, 2024
Report 8010908-2024-00001 · MDR key 20841409
Device
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
65 YR · Female
- Burning Sensation
- Swelling/ Edema
- Burning Sensation
- Swelling/ Edema
Narrative
Description of Event or Problem
A PATIENT HAS REPORTED THAT AFTER APPLYING VOCO PROFLUORID VARNISH MINT, HE HAD AN ALLERGIC REACTION THE FOLLOWING NIGHT: BURNING OF THE MUCOUS MEMBRANES AND SWELLING OF THE LIPS. SYMPTOMS LASTED 6 DAYS. NO HOSPITALISATION OR OTHER TREATMENT WAS REQUIRED. THE BATCH USED IS NOT KNOWN. THE PATIENT HAS MADE A FULL RECOVERY.