THOR PHOTOMEDICINE LTD

Description of Event or Problem

PRACTITIONER USED THE GLC ON A PATIENT WHO HAS HAD THIS SAME TREATMENT MANY TIMES. AFTER THEY GOT HOME, THEY REPORTED WHAT THEY THOUGHT LOOKED LIKE A BURN MARK ON THE SKIN, THE PATIENT DID NOT REPORT ANY DISCOMFORT OR SENSATION AT THE TIME OF TREATMENT.

Additional Manufacturer Narrative

THE PRACTITIONER REPORTED THAT THE PATIENT HAD PREVIOUSLY ATTENDED TEN APPOINTMENTS FOR THE SAME TREATMENT, USING THE SAME LASER PROBE, WITH IDENTICAL SETTINGS, DURATION, AND APPLICATION TO SOME OF THE SAME BODY AREAS, WITHOUT ANY ADVERSE EFFECTS. SINCE THE PATIENT REPORTED THIS EVENT, THE PRACTITIONER NOTED THAT THE PATIENT REMAINED FINE AND UNCONCERNED. THEY ALSO NOTED THAT THE SAME PROBE HAD BEEN USED SUBSEQUENTLY ON SEVERAL OTHER PATIENTS, STAFF MEMBERS, AND EVEN THEMSELVES WITHOUT ANY REPORTS OF HEATING, BURNING, OR OTHER ADVERSE EFFECTS. SINCE 2021, OVER 100 OF THESE PROBES HAVE BEEN IN REGULAR USE, TYPICALLY MULTIPLE TIMES PER DAY, RESULTING IN THOUSANDS OF PATIENT TREATMENTS WITHOUT ANY REPORTED ADVERSE EVENTS. ADDITIONALLY, EXPERIMENTAL USE OF THE PROBE FOR UP TO SIX MINUTES ON A SINGLE ANATOMICAL LOCATION REVEALED NO SIGNIFICANT HEATING OR ADVERSE EFFECTS. INVESTIGATIONS ARE ONGOING TO DETERMINE WHETHER OTHER FACTORS CONTRIBUTED TO OR CAUSED THIS INCIDENT. THE PROBE HAS BEEN REQUESTED TO BE RETURNED FOR TESTING.