MalfunctionILY
810NM 1W CLUSTER (5X200MW) ISSUE 1
Received Dec 7, 2023 · Event occurred Feb 2, 2021
Report 3003899624-2023-00011 · MDR key 18280668
Device
Product problems
- Excessive Heating
- Excessive Heating
Patient
Unknown
- Burning Sensation
- Burning Sensation
Narrative
Description of Event or Problem
ACCORDING TO A THERAPIST, ONE PROBE, SERIAL NUMBER (B)(6), FEELS HOT TO PATIENTS OF COLOR.
Additional Manufacturer Narrative
THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THIS EVENT IS BEING FILED IN ACCORDANCE WITH A CAPA WHICH HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.