REVANESSE VERSA+ 1.2 ML

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE PATIENT, ON (B)(6) 2021 - DATE OF TREATMENT WITH REVANESSE VERSA+ INJECTED IN THE CHIN AND MARIONETTE LINES AREA OF THE PATIENT. THE VOLUME INJECTED IS 1.2 ML. PATIENT IS (B)(6); DATE OF BIRTH IS (B)(6). SEX AND RACE IS UNKNOWN. IT IS UNKNOWN IF THIS WAS A FIRST DERMAL FILLER TREATMENT. AS REPORTED BY INJECTOR, PATIENT HA NOTIFIED THE INJECTOR THREE WEEKS LATER OF NODULES IN THE CHIN, NO OTHER SYMPTOMS. NODULES PALPATED, GOOD CAP REFILL, NO SIGNS OF VO. PATIENT STARTED ANTIBIOTICS, EVOSE FOLLOW-UP QA/RA DEPARTMENT HAS ATTEMPTED TO REACH OUT TO CLINIC MULTIPLE TIMES REQUESTING ADDITIONAL INFORMATION FOR INVESTIGATIONAL PURPOSES, HOWEVER, REQUESTED INFORMATION HAS NOT BEEN PROVIDED AS OF 21 JAN 2022. QA DEPARTMENT WILL CONTINUE THE INVESTIGATION.

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT IS IN THE PROCESS OF BEING ADEQUATELY INVESTIGATED. THE LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO PREVIOUS CLINICAL COMPLAINT HAS BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WILL BE PROVIDED TO THE CLINIC ALONG WITH THE LETTER STATING APPROVED INDICATION FOR THE REVANESSE VERSA+ PRODUCT LINE ONCE REQUESTED INFORMATION IS RECEIVED.