InjuryILY
COMPANION
Received Feb 11, 2026 · Event occurred Jan 14, 2026
Report 9616086-2026-00003 · MDR key 24319141
Device
Generic name
Lts-2501-c-s8 (cts-duo) System
Manufacturer
Litecure, Llc A Djo Llc CompanyModel number
SYS-000812-000-01Product problems
- Temperature Problem
Patient
NA · Unknown
- Burn(s)
Narrative
Additional Manufacturer Narrative
USER REPORTED TREATMENT HEADS ARE OVERHEATING DURING TREATMENT. WHEN TESTING THE HEAD ON THEMSELVES, THEY RECEIVED A BURN BLISTER. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, 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
USER REPORTED TREATMENT HEADS ARE OVERHEATING DURING TREATMENT. WHEN TESTING THE HEAD ON THEMSELVES, THEY RECEIVED A BURN BLISTER.