COMPANION
Received Mar 18, 2026 · Event occurred Feb 17, 2026
Report 9616086-2026-00007 · MDR key 24634384
Device
Product problems
- Temperature Problem
Patient
NA · Unknown
- Burn(s)
Narrative
Additional Manufacturer Narrative
CUSTOMER REPORTS LASER HAS BEEN BURNING PATIENTS RECENTLY. CUSTOMER TESTED IN ON THEIR SKIN AND THEY BURNED THEMSELVES - SAME THING HAPPENED WITH ANOTHER STAFF MEMBER. THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION; THE COMPLAINT COULD NOT BE CONFIRMED; THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF NEW INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
CUSTOMER REPORTS LASER HAS BEEN BURNING PATIENTS RECENTLY. CUSTOMER TESTED IN ON THEIR SKIN AND THEY BURNED THEMSELVES - SAME THING HAPPENED WITH ANOTHER STAFF MEMBER.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED AND EVALUATED BY A TECHNICIAN UNIT RAN MULTIPLE SETTINGS AND THE POWER OUTPUT IS WITHIN SPECIFICATIONS. THE UNIT IS NOT OVERPOWERING. A VERIFICATION FILE WAS RAN AND PASSED. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE ESTABLISHED.