Description of Event or Problem · 0
CUSTOMER SUBMITTED INFORMATION REGARDING 3 INCIDENTS: 1. FIRST INCIDENT INVOLVED A PATIENT THAT REPORTED A BIKINI BURN FROM (B)(6), 2025. THE BIKINI AREA TREATMENT WAS PERFORMED AT 14J 2HZ. FT SHOULD BE NOTED THAT THIS WAS THE NINTH TREATMENT IN THE SERIES; NO COMPLICATIONS HAVE EVER OCCURRED, AND THE PREVIOUS TREATMENT ON (B)(6), 2025, WAS PERFORMED AT 15J 2HZ. 2. SECOND INCIDENT REPORTED THAT A PATIENT'S FIRST PROCEDURE WAS PERFORMED ON (B)(6), 2025 AT 24/26J 3HZ. THE SECOND PROCEDURE WAS PERFORMED ON (B)(6), 2025, AT 20/22J 3HZ AND THE PATIENT REPORTED SEVERE PAIN DURING THE PROCEDURE. DURING THE INTERVIEW, THE PATIENT DID NOT REPORT ANY CHANGES IN HER CONSENT REGARDING CONTRAINDICATIONS. 3. THIRD INCIDENT THE PATIENT REPORTED DISCOLORATION FOLLOWING A LASER HAIR REMOVAL TREATMENT ON (B)(6), 2025. THIS WAS THE EIGHTH HAIR REMOVAL TREATMENT IN A SERIES PERFORMED AT 20J 2HZ. ON THAT DAY, PATIENT REPORTED INCREASED DISCOMFORT DURING THE TREATMENT. ACCORDING TO THE REPORT, THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE AND NO OTHER, DAMAGE, TECHNICAL OR MECHANICAL ISSUES REPORTED. BASED ON THE AVAILABLE DOCUMENTATION, INCLUDING THE INCIDENT DESCRIPTION, PHOTOGRAPHIC MATERIAL, AND THE TECHNICAL VERIFICATION, AT THIS STAGE THERE IS NO BASIS TO CONCLUDE THAT THE INCIDENT WAS CAUSED BY A DESIGN OR MATERIAL DEFECT IN THE PRODUCT. THE DEVICE AND THE HEAD WERE TECHNICALLY INSPECTED, AND THE TESTS PERFORMED DID NOT CONFIRM ANY IRREGULARITIES THAT COULD CLEARLY INDICATE PRODUCT DAMAGE AS THE DIRECT CAUSE OF THE REPORTED POST-TREATMENT REACTION. ANALYSIS OF THE ENTIRE MATERIAL INDICATES THAT PROCEDURAL FACTORS AND THE INDIVIDUAL CHARACTERISTICS OF THE TREATMENT AREA MAY HAVE PLAYED A SIGNIFICANT ROLE. PHOTOGRAPHIC DOCUMENTATION INDICATES THE POSSIBLE PRESENCE OF A TAN, DIFFICULTY IN CLEARLY ASSESSING THE PATIENT'S SKIN PHOTOTYPE, AND A LOCALIZED REACTION, LOCATED IN THE TIBIA AREA. THIS MAY INDICATE THE INFLUENCE OF PROCEDURAL FACTORS, INCLUDING THE TECHNIQUE OF GUIDING THE APPLICATOR AND MAINTAINING FULL CONTACT WITH THE SKIN SURFACE DURING OPERATION. THE INFLUENCE OF EXTERNAL FACTORS ON THE PATIENT'S PART, INCLUDING THE USE OF PREPARATIONS OR COSMETICS IN THE TREATMENT AREA, WHICH MAY HAVE INFLUENCED THE SKIN REACTION, CANNOT BE RULED OUT.