Description of Event or Problem · 0
A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE ALMA HARMONY SYSTEM. THE FACILITY FURTHER REPORTED THAT THE CLEARSKIN HANDPIECE USED WITH THE ALMA HARMONY SYSTEM DURING THE TREATMENT BEGAN LEAKING WATER AFTER THE BURN OCCURRED. ALMA LASERS INC. CONDUCTED AN INITIAL INVESTIGATION AND DETERMINED THAT THE REPORTED BURN APPEARED SUPERFICIAL AND WAS EXPECTED TO RESOLVE. DURING FOLLOW-UP COMMUNICATION WITH THE USER FACILITY ON FEBRUARY 5, 2026, THE FACILITY ALLEGED THAT THE PATIENT SUBSEQUENTLY DEVELOPED A SCAR AS A RESULT OF THE BURN. NO UPDATED PHOTOGRAPHS OR ADDITIONAL CLINICAL DOCUMENTATION WERE PROVIDED TO SUPPORT THIS ALLEGATION. THIS EVENT IS BEING REPORTED IN GOOD FAITH. ALMA LASERS INC. HAS MADE DUE DILIGENCE EFFORTS TO OBTAIN THE DEVICE FOR FURTHER EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED BY THE USER FACILITY.