inforMED
InjuryISA

VIORA INC.

Received Aug 8, 2025

Report 3010927849-2025-00003 · MDR key 22747277

Device

Generic name

V-fr Handpiece

Manufacturer

Viora Inc.

Model number

V-FR2002

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

NA · Female

  • Superficial (First Degree) Burn
  • Superficial (First Degree) Burn

Narrative

Additional Manufacturer Narrative

DEVICE INVESTIGATION IS ONGOING.

Description of Event or Problem

PATIENT PRESENTED WITH A BURN ON THE ARM FOLLOWING V-FR TREATMENT.

Remedial action

  • Patient Monitoring