REVANESSE LIPS+

Additional Manufacturer Narrative

DUE TO LIMITED INFORMATION, PROLLENIUM COULD NOT COMPLETE INTERNAL INVESTIGATION INCLUDING REVIEW THE BATCH RECORD, QC TEST REPORTS, AND QC FINAL INSPECTION REVIEW CHECK LIST.

Description of Event or Problem

ON THURSDAY, (B)(6) 2026, A FEMALE PATIENT CONTACTED ANSWERCONNECT TO REPORT AN ADVERSE EVENT. ACCORDING TO THE PATIENT, SHE RECEIVED INJECTIONS OF REVANESSE® LIPS+ IN HER LIPS. SHE REPORTED ASYMMETRY OF THE LIPS, NOTING THAT THE RIGHT SIDE APPEARED FULLER THAN THE LEFT SIDE FOLLOWING THE TREATMENT. THE PATIENT EXPRESSED CONCERN REGARDING THIS OUTCOME AND REQUESTED TO SPEAK WITH A CONTACT PERSON FROM PROLLENIUM TO OBTAIN ASSISTANCE IN RESOLVING THE ISSUE. THE PATIENT DECLINED TO DISCLOSE THE NAME OF THE CLINIC OR HEALTHCARE PROVIDER WHERE THE INJECTION WAS ADMINISTERED. NO FURTHER DETAILS WERE AVAILABLE REGARDING THE PRODUCT, INCLUDING LOT NUMBER, OR REGARDING THE PATIENT'S DEMOGRAPHIC OR MEDICAL BACKGROUND (E.G., AGE, MEDICAL HISTORY). ADDITIONALLY, NO INFORMATION WAS PROVIDED ON THE INJECTOR AND TREATMENT PLAN, INCLUDING DOSAGE, INJECTION TECHNIQUE, OR PRE OR POST TREATMENT CARE. FOLLOWING RECEIPT OF THE REPORT, THE PROLLENIUM MEDICAL AFFAIRS TEAM ATTEMPTED TO CONTACT THE PATIENT MULTIPLE TIMES (B)(6) 2026, USING THE PHONE NUMBER SHE PROVIDED IN ORDER TO OBTAIN ADDITIONAL. HOWEVER, THE PATIENT DID NOT ANSWER THE PHONE. DUE TO THE LIMITED INFORMATION AVAILABLE, PROLLENIUM WAS UNABLE TO COMPLETE THE INTERNAL INVESTIGATION, INCLUDING A REVIEW OF THE BATCH RECORDS AND QC TESTING RECORDS. THE LIMITED INFORMATION RECEIVED WAS REVIEWED BY THE PROLLENIUM MEDICAL DIRECTOR, WHOSE CLINICAL OPINION IS PROVIDED BELOW: ASSESSMENT: BASED ON THE LIMITED INFORMATION AVAILABLE, THE REPORTED CONCERN IS ISOLATED LIP ASYMMETRY FOLLOWING DERMAL FILLER INJECTION, WITHOUT ASSOCIATED INFLAMMATORY OR VASCULAR FEATURES. LIP ASYMMETRY IS A RECOGNIZED POST-PROCEDURAL OUTCOME IN AESTHETIC LIP AUGMENTATION AND MAY RESULT FROM UNEVEN PRODUCT DISTRIBUTION, INJECTION TECHNIQUE VARIABILITY, OR PRE-EXISTING ANATOMICAL ASYMMETRY. LIMITATIONS A DEFINITIVE MEDICAL ASSESSMENT REMAINS LIMITED DUE TO ABSENCE OF: TREATMENT DETAILS (VOLUME, TECHNIQUE, INJECTION PLANE) CLINICAL DOCUMENTATION OR IMAGING BASELINE ANATOMICAL ASSESSMENT FOLLOW-UP EVALUATION. CATEGORY: NON-ADVERSE AESTHETIC OUTCOME. (POST-PROCEDURAL ASYMMETRY) CAUSALITY ASSESSMENT: DEVICE-RELATED DEFECT - UNLIKELY PROCEDURE-RELATED OUTCOME - LIKELY OTHER CONTRIBUTING FACTORS. (E.G., BASELINE ASYMMETRY) - POSSIBLE OVERALL CLASSIFICATION: CONSISTENT WITH A NON-MEDICAL, TECHNIQUE-RELATED AESTHETIC OUTCOME. CORRECTIVE ACTION: NO CORRECTIVE ACTION RELATED TO PRODUCT QUALITY OR MANUFACTURING IS INDICATED BASED ON THE AVAILABLE INFORMATION. CLINICAL FOLLOW-UP WITH A QUALIFIED INJECTOR MAY BE CONSIDERED TO ASSESS SYMMETRY AND DETERMINE WHETHER MINOR CORRECTIVE TREATMENT IS APPROPRIATE. (B)(4)