InjuryNXV
VIZILITE PRO
Received Aug 8, 2018
Report MW5078943 · MDR key 7768247
Device
Generic name
Vizilite Pro
Manufacturer
Den-mat Holdings LlcProduct problems
- Insufficient Device Problem Information
Patient
52 YR
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
HI, I WENT TO (B)(6), FOR MY DENTAL APPT. I GOT VIZILITE PRO, ORAL LESION SCREENING SYSTEM TO SCREEN CANCER. I AM NOT SURE IF THIS INSTRUMENT WAS FDA/CDRH CLEARED / APPROVED. ANYWAY, AS TODAY THREE DAYS LATER, I STILL FEEL MY TONGUE WAS BURNT, NOT COMFORTABLE.