SOFWAVE

Additional Manufacturer Narrative

THIS SUBMISSION IS A FOLLOW UP TO MDR REPORT NUMBER 3015889734 2025 00054 AND IS PROVIDED PURSUANT TO 21 CFR §803.56 TO REPORT NEW INFORMATION OBTAINED AFTER THE INITIAL MDR SUBMISSION. ON MARCH 1, 2026, THE MANUFACTURER RECEIVED INFORMATION FROM THE TREATING CLINIC REGARDING THE REPORTED TREATMENT. THE CLINIC REPORTED THAT THE SUBJECT, A 49 YEAR OLD FEMALE, UNDERWENT TREATMENT ON (B)(6), 2024 INVOLVING THE FULL FACE, BROWS, AND SUBMENTUM. TREATMENT WAS PERFORMED USING A LIFT APPLICATOR AT REPORTED ENERGY SETTINGS OF APPROXIMATELY 3.6-4.2 J. THE CLINIC REPORTED USE OF TOPICAL ANESTHETIC (BLT) APPLIED FOR APPROXIMATELY 60 MINUTES PRIOR TO TREATMENT, AS WELL AS ADDITIONAL PAIN MANAGEMENT MEASURES DURING THE PROCEDURE. THE CLINIC FURTHER REPORTED THAT APPROXIMATELY THREE MONTHS FOLLOWING THE TREATMENT, THE PATIENT COMPLAINED OF SYMPTOMS DESCRIBED AS "FAT ATROPHY" AND "SENSORY NERVE DAMAGE." THE CLINIC INDICATED THAT THE PATIENT WAS REPORTEDLY SEEKING ADDITIONAL MEDICAL MANAGEMENT, INCLUDING FAT TRANSFER AND GABAPENTIN. THE CLINIC DID NOT REPORT ANY DEVICE MALFUNCTION DURING THE TREATMENT. THE TREATING CLINIC DID NOT DIAGNOSE OR DOCUMENT OBJECTIVE EVIDENCE OF TISSUE INJURY, FAT ATROPHY, NERVE DAMAGE, OR OTHER DEVICE RELATED PATHOLOGY. THE CLINIC CHARACTERIZED THE PATIENT'S CONCERNS AS SUBJECTIVE PERCEPTIONS OF AESTHETIC CHANGE AND MANAGED THE MATTER WITHIN AN ELECTIVE COSMETIC CONTEXT RATHER THAN AS A CONFIRMED ADVERSE TISSUE INJURY. FOLLOWING RECEIPT OF THE CLINIC PROVIDED INFORMATION, THE MANUFACTURER REOPENED THE INVESTIGATION AND CONDUCTED ADDITIONAL REVIEW ACTIVITIES. THESE INCLUDED IDENTIFICATION OF THE RELEVANT DEVICE AND APPLICATOR, REVIEW OF AVAILABLE TREATMENT LOG DATA FROM THE REPORTED TREATMENT DATE, AND EVALUATION OF THE APPLICATOR ONCE IT BECAME AVAILABLE TO THE MANUFACTURER. REVIEW OF THE CONTEMPORANEOUS TREATMENT LOGS FROM THE REPORTED TREATMENT DATE DID NOT IDENTIFY ABNORMAL FINDINGS, ALARMS, OR DEVICE MALFUNCTION ASSOCIATED WITH THE REPORTED TREATMENT. THE APPLICATOR ASSOCIATED WITH THE REPORTED TREATMENT WAS RECEIVED AND EVALUATED AFTER IT HAD BEEN REPLACED AT THE USER FACILITY. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. THE APPLICATOR EVALUATION WAS CONDUCTED AFTER A SIGNIFICANT TIME HAD ELAPSED SINCE THE REPORTED TREATMENT DATE; THEREFORE, THE CONDITION OF THE APPLICATOR AT THE TIME OF EVALUATION MAY NOT BE REPRESENTATIVE OF ITS CONDITION AT THE TIME OF THE REPORTED TREATMENT. CERTAIN OBSERVATIONS WERE NOTED DURING APPLICATOR EVALUATION; HOWEVER, THERE IS NO EVIDENCE TO ESTABLISH THAT THESE OBSERVATIONS WERE PRESENT AT THE TIME OF THE REPORTED TREATMENT. IF SUCH CONDITIONS HAD BEEN PRESENT DURING THE REPORTED TREATMENT, THEY WOULD BE EXPECTED TO BE REFLECTED IN CONTEMPORANEOUS TREATMENT LOGS, WHICH DID NOT DEMONSTRATE ABNORMAL FINDINGS. BASED ON REVIEW OF CLINIC PROVIDED INFORMATION, CONTEMPORANEOUS TREATMENT LOGS, AND APPLICATOR EVALUATION, THE MANUFACTURER DID NOT IDENTIFY EVIDENCE OF A DEVICE MALFUNCTION DURING THE REPORTED TREATMENT. THE REPORTED OUTCOMES REMAIN BASED ON PATIENT ALLEGATIONS. OBJECTIVE CLINICAL EVIDENCE ESTABLISHING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED OUTCOMES IS NOT AVAILABLE. THE INVESTIGATION WAS LIMITED BY THE TIME ELAPSED BETWEEN THE REPORTED TREATMENT DATE AND AVAILABILITY OF THE APPLICATOR FOR EVALUATION. THIS FOLLOW UP SUBMISSION IS PROVIDED AS PART OF THE MANUFACTURER'S ROUTINE POST MARKET SURVEILLANCE OBLIGATIONS UNDER 21 CFR PART 803 AND DOES NOT REPRESENT AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

Description of Event or Problem

ON OCTOBER 21, 2025, SOFWAVE RECEIVED A REPORT FROM FDA DESCRIBING AN EVENT ALLEGING LAXITY, THINNING, SAGGING AND DESCENT, ASYMMETRICAL VOLUME LOSS, FAT AND TISSUE ATROPHY, LOSS OF ELASTICITY, INFLAMMATION AND SIGNIFICANT PSYCHOLOGICAL AND EMOTIONAL INJURY, (MW5176208-1) BY THE PATIENT. THE INFORMATION WAS LIMITED AND SEVERAL FIELDS WERE REDACTED. PATIENT CONTACT INFORMATION WAS NOT AVAILABLE AND THEREFORE FURTHER FOLLOW-UP WITH THE PATIENT AND INVESTIGATION WAS NOT POSSIBLE. THE MANUFACTURER WAS UNABLE TO DETERMINE WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INJURIES DUE TO THE LACK OF CLINICAL, PROCEDURAL, AND PATIENT-SPECIFIC INFORMATION. IN ACCORDANCE WITH 21 CFR PART 803, A REPORT WAS SUBMITTED TO THE FDA BASED ON THE PATIENT'S ALLEGATION OF SERIOUS INJURY (COMPLAINT #(B)(4) FROM OCT 30, 2025). ALTHOUGH THE AVAILABLE INFORMATION WAS LIMITED, THE SUBMISSION WAS MADE OUT OF AN ABUNDANCE OF CAUTION AND IN COMPLIANCE WITH THE REQUIREMENTS OF 21 CFR PART 803. ON JANUARY 15, 2026, SOFWAVE BECAME AWARE ON A COMPLAINT FROM A PATIENT THAT REPORTED ON SIMILAR SYMPTOMS AND PROVIDED THE CLINIC NAME AND THE TREATMENT DATE. THE SUBJECT DEMOGRAPHIC, THE TREATMENT DATE ((B)(6) 2024) AND THE INJURY SYMPTOMS ARE ALIGNED WITH THE PREVIOUS COMPLAINT AND THEREFORE, THE MANUFACTURER BELIEVES THIS IS THE SAME EVENT AND THE INVESTIGATION WAS RE-OPENED AND EVALUATED FOR ADDITIONAL INFORMATION. ON MARCH 1, 2026 THE FOLLOWING INFORMATION WAS OBTAINED FROM THE CLINIC: SUBJECT WAS TREATED ON FULL FACE, BROWS AND SUBMENTUM. BLT PRE-TREATMENT SEDATION WAS USED FOR 60 MINUTES. ZIMMER OR PRONOX WAS USED AS ADDITIONAL PAIN MANAGEMENT DURING TREATMENT. TREATMENT WAS PERFORMED WITH LIFT APPLICATOR AND ENERGY LEVELS OF 3.6-4.2J. APPROXIMATELY THREE MONTHS AFTER THE TREATMENT, THE PATIENT COMPLAINED ABOUT "FAT ATROPHY" AND "SENSORY NERVE DAMAGE". THE PATIENT WAS SEEKING FAT TRANSFER AND GABAPENTIN FOR NERVE PAIN. FOR MDR FOLLOW-UP PURPOSES, SOFWAVE CONSIDERS (B)(6), 2026 TO BE THE TRIGGERING DATE BECAUSE THAT IS WHEN THE MANUFACTURER FIRST OBTAINED NEW, SUBSTANTIVE INVESTIGATION INFORMATION FROM THE TREATING CLINIC THAT WAS NOT AVAILABLE AT THE TIME OF THE INITIAL MDR AND THAT MATERIALLY SUPPLEMENTS THE INVESTIGATION RECORD (E.G., ANATOMIC AREAS TREATED; USE OF BLT TOPICAL ANESTHETIC FOR 60 MINUTES; ADDITIONAL PAIN MANAGEMENT WITH ZIMMER AND/OR PRONOX; USE OF THE LIFT APPLICATOR; ENERGY RANGE 3.6-4.2 J; AND DOCUMENTATION THAT APPROXIMATELY THREE MONTHS POST-TREATMENT THE PATIENT REPORTED "FAT ATROPHY" AND "SENSORY NERVE DAMAGE" AND SOUGHT FAT TRANSFER AND GABAPENTIN). INFORMATION RECEIVED ON JANUARY 15, 2026 WAS ASSESSED AS A COMPLAINT DESCRIBING A PREVIOUSLY REPORTED, SAME-EVENT SCENARIO (SAME CLINIC AND TREATMENT DATE [(B)(6) 2024] WITH SUBSTANTIALLY SIMILAR ALLEGED OUTCOMES) AND DID NOT PROVIDE ADDITIONAL DEVICE/PROCEDURAL DETAILS OR THIRD PARTY CLINICAL INFORMATION THAT WOULD CHANGE THE INVESTIGATION BEYOND REOPENING THE FILE FOR FOLLOW-UP; THEREFORE, (B)(6) 2026 WAS NOT CONSIDERED THE TRIGGERING DATE FOR THIS SUPPLEMENTAL MDR. FOLLOW UP IS BEING SUBMITTED TO PROVIDE ADDITIONAL INVESTIGATION INFORMATION THAT WAS NOT AVAILABLE AT THE TIME OF THE INITIAL MDR AND WAS OBTAINED RECENTLY.