REVANESSE VERSA+(WITH LIDOCAINE) 1.2 ML

Additional Manufacturer Narrative

THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER 22F077 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. AS PER THE INFORMATION PROVIDED, PROLLENIUM CONSIDERS THE REPORTED AE AS A PENDING ASSESSMENT WITH NO AE DUE TO THE PRODUCT. THE INFORMATION PROVIDED BY THE PATIENT HAS BEEN SUBMITTED TO THE PROLLENIUM MEDICAL DIRECTOR FOR REVIEW.

Description of Event or Problem

BASED ON THE INFORMATION/REPORT PROVIDED BY A PATIENT THROUGH ANSWER CONNECT AND LATER BY THE CLINIC, SHE WAS INJECTED WITH A 1.2 ML REVANESSE VERSA+ (WITH LIDOCAINE) IN LIPS. TOPICAL LIDOCAINE 23% TERACAINE 7% WAS APPLIED BEFORE THE INJECTION. 8 HOURS LATER, THE PATIENT CLAIMED THAT SHE GOT LUMPS IN HER LIPS AND SENT SOME IMAGES. THE PATIENT WOULD NOT COME BACK FOR A FOLLOW-UP APPOINTMENT. THE PATIENT ALSO COMMENTED THAT SHE HAD A LUMP IN HER LIP FROM PREVIOUS INJECTION. THE PATIENT STATED THAT SHE HAS GONE TO ANOTHER INJECTOR TO HAVE HYALURONIDASE INJECTED. SHE HAS HAD ONE SESSION OF HYLENEX INJECTED AND FEELS MOST OF THE LUMPS ARE GONE AFTER THIS ONE TREATMENT. THE BATCH RECORD, QC TEST REPORTS (10-JUN-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (20-JUN-2022) WERE ANALYZED AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER 22F077 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. AS PER THE INFORMATION PROVIDED, PROLLENIUM CONSIDERS THE REPORTED AE AS A PENDING ASSESSMENT WITH NO AE DUE TO THE PRODUCT. THE INFORMATION PROVIDED BY THE PATIENT HAS BEEN SUBMITTED TO THE PROLLENIUM MEDICAL DIRECTOR FOR REVIEW. THE PROLLEIUM MEDICAL DIRECTOR'S CLINICAL OPINION WILL BE SUBMITTED IN THE FOLLOW-UP REPORT. INTERNAL PROLLENIUM COMPLAINT NUMBER: (B)(4).