THOR PHOTOMEDICINE LTD

Additional Manufacturer Narrative

THE CUSTOMER DID NOT RETURN THE PRODUCT FOR INVESTIGATION. 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.

Description of Event or Problem

ONE PROBE GETS TOO HOT FOR COMFORT AFTER ABOUT 10 MINUTES OF USE, THE OTHER PROBE DOES NOT GET UNCOMFORTABLY HOT AT ALL, NO MATTER HOW LONG IT IS USED.