COMPANION
Received Feb 11, 2026 · Event occurred Jan 9, 2026
Report 9616086-2026-00004 · MDR key 24319158
Device
Product problems
- Temperature Problem
Patient
NA · Unknown
- Burn(s)
Narrative
Additional Manufacturer Narrative
USER REPORTED THAT A PATIENT HAS DERMAL BURN AFTER A LASER TREATMENT. THE BURNS OCCURRED HOURS AFTER THE TREATMENT HAD COMPLETED. THE DEVICE WAS RETURNED AND INSPECTED. INSPECTION YIELDED OUTDATED SOFTWARE, BROKEN H/P CLIP, SHORTED H/P, OUT OF WARRANTY BATTERY AND INCOMPATIBLE POWER SUPPLY. UPDATED SOFTWARE REPLACED H/P CLIP, H/P, BATTERY, POWER SUPPLY AND TESTED. UNIT PASSED ALL POWER TESTING. FIRMWARE/SOFTWARE ARE UP TO DATE. THERE IS NO FURTHER INFORMATION PROVIDED THE COMPLAINT WAS NOT CONFORMED AND THE ROOT CAUSE WAS NOT ESTABLISHED.
Additional Manufacturer Narrative
USER REPORTED THAT A PATIENT HAS DERMAL BURN AFTER A LASER TREATMENT. THE BURNS OCCURRED HOURS AFTER THE TREATMENT HAD COMPLETED. 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 THAT A PATIENT HAS DERMAL BURN AFTER A LASER TREATMENT. THE BURNS OCCURRED HOURS AFTER THE TREATMENT HAD COMPLETED.