SOFWAVE

Additional Manufacturer Narrative

A PATIENT UNDERWENT TREATMENT ON (B)(6) 2026 ON FACE, NECK, AND SUBMENTAL WITH LIFT APPLICATOR. A BURN WAS OBSERVED ON THE TREATMENT DAY IN THE NASOLABIAL FOLD AND MARIONETTE LINE. ON (B)(6) 2026 HYPERPIGMENTATION WAS DEVELOPED IN THE AFFECTED AREA. AN INVESTIGATION WAS PERFORMED WHICH INVOLVED DIRECT COMMUNICATION WITH THE CLINIC AS WELL AS TESTING THE APPLICATOR WHICH DEMONSTRATED PERFORMANCE AS EXPECTED. NO MALFUNCTION WAS FOUND. PHOTOGRAPHS FROM (B)(6) 2026 AND (B)(6) 2026 DEMONSTRATED RESOLUTION OF THE BURNS, WITH ONLY RESIDUAL HYPERPIGMENTATION REMAINING IN THE LEFT MARIONETTE REGION, WHICH ALREADY HAD SHOWN IMPROVEMENT. THE RESIDUAL HYPERPIGMENTATION IS EXPECTED TO FURTHER IMPROVE AND RESOLVE OVER TIME. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION WE ARE REPORTING THIS EVENT.

Description of Event or Problem

A PATIENT UNDERWENT TREATMENT ON (B)(6) 2026 ON FACE, NECK, AND SUBMENTAL WITH LIFT APPLICATOR, ENERGY 3.2J, POST COOLING 1-2 SECONDS, IN SINGLE MODE. TOTAL OF 220 PULSES WERE PERFORMED. PRIOR TO TREATMENT TOPICAL LIDOCAINE/TETRACAINE 23%/7% CREAM WAS APPLIED AS PRE-TREATMENT SEDATION. VIBRATION AND SQUEEZE BALL WERE USED AS OTHER PAIN MANAGEMENT. A BURN WAS OBSERVED ON THE TREATMENT DAY IN THE NASOLABIAL FOLD AND MARIONETTE REGIONS. ON (B)(6) 2026, HYPERPIGMENTATION WAS DEVELOPED IN THE AFFECTED AREA. THE PATIENT RECEIVED A SINGLE PROPHYLACTIC DOSE OF VALTREX® 1 G IN THE CLINIC AND BACTERIAL AND VIRAL CULTURES, INCLUDING HSV PCR TESTING, WERE TAKEN WITH NEGATIVE RESULTS. THE PHYSICIAN FURTHER INSTRUCTED THE PATIENT TO TAKE VALTREX® 500 MG ORALLY TWICE DAILY (BID) FOR 5 DAYS, AND TO APPLY SILVER SULFADIAZINE 1% (SSD) TOPICAL CREAM TO THE AFFECTED AREA SEVERAL TIMES DAILY, COVERED WITH TELFA GAUZE DRESSING. PHOTOGRAPHS OBTAINED ON (B)(6) 2026 AND ON (B)(6) 2026 DEMONSTRATED RESOLUTION OF THE BURNS, WITH ONLY RESIDUAL HYPERPIGMENTATION REMAINING IN THE LEFT MARIONETTE REGION, WHICH ALREADY HAD SHOWN IMPROVEMENT.