REVANESSE VERSA+ 1.2 ML

Description of Event or Problem

ACCORDING TO THE INJECTOR, PA-C, A 35-YEAR-OLD FEMALE PATIENT WAS INJECTED WITH 0.2 ML OF REVANESSE VERSA+ INTO HER TOP RIGHT UPPER LIP. THE PATIENT HAD A HISTORY OF LIP SORES AND TOOK VALTREX BEFORE THE INJECTION. THE INJECTOR ASPIRATED BEFORE EACH INJECTION & SHOWED GOOD CAPILLARY REFILL AFTER INJECTION. THE INJECTOR ASKED IF PATIENT WAS IN PAIN, PT. SAID THERE WAS PAIN BUT NOT INTENSE. ON DAY 2, THE PATIENT EXPERIENCED INTENSE PAIN (9/10). THE RIGHT UPPER LIP'S VERMILION BORDER DEVELOPED A HEMATOMA. THE PATIENT WAS REFERRED TO DR. SAYEED IN PLASTICS, WHO USED TWO VIALS OF HYLENEX TO FLUSH OUT A POSSIBLE VASCULAR OCCLUSION (VO). ON DAY 3, THE PATIENT REPORTED BLURRY VISION, AND A CTA OF THE HEAD AND NECK CAME BACK NORMAL. BY DAY 4, THE PATIENT HAD BRUISING EXTENDING ABOVE THE LIP, WITH NORMAL PAIN AND SENSATION. BRUISING PERSISTS. THE PLASTIC SURGEON SUSPECTS THIS MAY BE A CASE OF VASCULAR OCCLUSION IN THE UPPER LIP. THE PT. GOT A SECOND OPINION BY DR. (B)(6) IN (B)(6); WHO DIAGNOSED HER WITH ECCHYMOSIS. THE INFORMATION PROVIDED BY THE CLINIC AND THE PATIENT HAS BEEN SUBMITTED TO THE PROLLENIUM'S MEDICAL DIRECTOR FOR REVIEW. THE MEDICAL DIRECTOR'S OPINION ABOUT THE REPORTED AE IS AS FOLLOWS: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2025 A PATIENT RECEIVED 0.2CC OF REVANESSE VERSA+ INTO HER RIGHT UPPER LIP. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THE POST TREATMENT PHOTO SHOWED NO BRUISES, NODULES OR VASCULAR COMPROMISE. ONE DAY LATER THE PATIENT CONTACTED THE CLINIC COMPLAINING OF "INTENSE PAIN" AND BRUISING IN THE INJECTION AREA. THE PATIENT WAS SEEN BY A PLASTIC SURGEON WHO USED 2 VIALS OF HYLENEX TO DISSOLVE ANY PRODUCT IN THE AREA. THERE WAS NO RECORD OF TISSUE DAMAGE OR NECROSIS. NO PHOTOS WERE PROVIDED. THE SURGEON SUSPECTED "A POSSIBLE VASCULAR OCCLUSION" BUT DID NOT OFFER A DEFINITIVE DIAGNOSIS. A SECOND PHYSICIAN, WHO WAS SOUGHT OUT BY THE PATIENT AS A SECOND OPINION, DIAGNOSED THE FINDINGS AND HISTORY AS A BRUISE. MY CLINICAL OPINION, BASED ON THE INFORMATION PROVIDED, IS THAT THIS CASE REPRESENTS A TREATMENT HEMATOMA (BRUISE). THE AREA WAS APPROPRIATELY TREAT AS A VASCULAR OCCLUSION, AS THIS IS A DIFFERENTIAL DIAGNOSIS THAT CAN NOT BE MISSED." INTERNAL AE NUMBER: (B)(4).

Additional Manufacturer Narrative

THE LOT NUMBER WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY PROLLEINUM. THE BATCH RECORD, QC TEST REPORTS AND QC FINAL INSPECTION REVIEW CHECKLIST WERE ANALYZED AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS.