LIGHTFORCE
Received Apr 29, 2026 · Event occurred Feb 5, 2025
Report 9616086-2026-00010 · MDR key 25031364
Device
Product problems
- Temperature Problem
Patient
NA · Unknown
- Burn(s)
Narrative
Additional Manufacturer Narrative
THE CUSTOMER HAS REPORTED THAT THERE WERE BURN-LIKE LESIONS ON THE PATIENT'S BACK. DEVICE NOT RETURNED FOR EVALUATION; PER THE INITIAL REPORTER THIS DEVICE WAS USED TO TREAT A 11.6LBS 11YRS SABLE POMERANIAN DOG FOR ARTHRITIS - CERVICAL SPINE. LAST LASER PERFORMED ON (B)(6) 2025 - PATIENT PRESENTED IN-CLINIC WITH LESIONS ON (B)(6) 2025. THE REPORTER STATES SHE MOVES IT ACCORDINGLY, AS IT THE HANDPIECE BUZZES IF NOT BEING MOVED FAST ENOUGH. ALTHOUGH, SHE DESCRIBES SHE LIKELY WENT UP AND DOWN IN THE SAME AREA, EVEN THOUGH SHE WAS MOVING THE HANDPIECE. THE REPORTER STATES PATIENT DID NOT ACT UNCOMFORTABLE DURING THE TREATMENT AND NO DEFECTS ON THE HANDPIECE OR TREATMENT HEADS. THE ROOT CAUSE COULD NOT BE ESTABLISHED AT THIS TIME. 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
THE CUSTOMER HAS REPORTED THAT THERE WERE BURN-LIKE LESIONS ON THE PATIENT'S BACK.