InjuryISA
VIORA INC.
Received Aug 7, 2025
Report 3010927849-2025-00002 · MDR key 22735799
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
43 YR · Female
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
THE PATIENT PRESENTED WITH A BURN ON THE LEFT LEG FOLLOWING A V-IPL TREATMENT. SINCLAIR HAS REQUESTED DETAILS REGARDING TREATMENT AND DEVICE PARAMETERS. INFORMATION ON THE ADDITIONAL TREATMENT IS CURRENTLY BEING COLLECTED. SEVERITY OF THE BURN WAS CONFIRMED BY IMAGES PROVIDED OF THE AFFECTED AREA.
Additional Manufacturer Narrative
DEVICE INVESTIGATION IS ONGOING.
Remedial action
- Patient Monitoring