REVANESSE VERSA+ 1.2 ML

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT HAS BEEN 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 COMPLAINTS HAVE 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 WAS PROVIDED TO THE CLINIC. THE RESPONSE FROM MEDICAL DIRECTOR IS AS FOLLOWS: "THE FOLLOWING IS A MEDICAL OPINION BASED ON THE INFORMATION PROVIDED BY THE INJECTING NP; THE AFTER PHOTOS PROVIDED ARE OF POOR QUALITY AND MAY HAVE BEEN TAKEN BY THE PATIENT. IT IS MY UNDERSTANDING THAT PRE PHOTOS WERE NOT TAKEN SO UNFORTUNATELY WE DO NOT HAVE A BEFORE IMAGE OF THE AREA FOR COMPARISON. THE PHOTOS PROVIDED SHOW OBVIOUS, SIGNIFICANT BRUISING BILATERALLY. THERE IS ALSO THE POSSIBILITY OF SOME SWELLING WHICH CANNOT BE CONFIRMED WITHOUT A BEFORE PHOTO FOR COMPARISON. THE HISTORY SUGGESTS THAT THE AREAS OF CONCERN HAD MULTIPLE " SERIAL RETROGRADE LINEAR INJECTIONS " FOLLOWED BY A " FANNING " INJECTION TECHNIQUE. THERE WAS ONLY A SMALL QUANTITY OF HA (0.3 MLS) INJECTED INTO THE AREAS. THE BRUISING AND POSSIBLE SWELLING IN THE AREA IS ENTIRELY IN KEEPING WITH NEEDLE TRAUMA FROM DOCUMENTED MULTIPLE SERIAL INJECTIONS. THIS WOULD ALSO EXPLAIN WHY THE CHANGES WERE STILL PRESENT TWO WEEKS LATER. IT IS ALSO IMPORTANT FOR THE INJECTOR TO RULE OUT ANY VASCULAR EVENT AS THE FACIAL ARTERY COURSES UNDER THIS AREA. A FINAL COMMENT IS THAT ALLERGIC REACTIONS TO BLT 20/10/10 ARE FAIRLY COMMON AND AS INJECTORS WE SHOULD BE AWARE THAT THIS IS AN UNTESTED FORMULA THAT WE USE IN AN OFF LABEL MANNER. I WOULD NOT EXPECT AN ALLERGIC REACTION TO LAST 2 WEEKS UNLESS THE TOPICAL WAS TATTOOED INTO THE SKIN FROM THE MULTIPLE INJECTION POINTS. I TRUST THIS MEDICAL OPINION IS OF VALUE TO ALL PARTIES INVOLVED IN THIS CASE."

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, ON (B)(6) 2021, PATIENT HAS BEEN INJECTED WITH 0.3 ML OF REVANESSE VERSA+. CLIENT HAS HAD VERSA+ SEVERAL TIMES WHICH SHE USED AS LIP FILLER. EXCESS FROM HER LIP FILLER WAS USED TO SUPERFICIALLY FILL SHALLOW BILATERAL SMILE LINES. SERIAL RETROGRADE LINEAR APPROACH USED ON 1ST PASS. FOLLOWED BY SUPPORTING FAN INJECTIONS PARALLEL TO LINES. LIGHT MASSAGE APPLIED. DISCOLORATION AND MALFORMED SMILE APPEARED TWO WEEKS LATER. NO COVID-19 VACCINE AS OF (B)(6) 2021 AND NO PLANS TO TAKE IT AS REPORTED. NO MEDICATIONS AFTER OR BEFORE TREATMENT. NO OTHER PROCEDURES. SAME SYRINGE PATIENT HAD IN HER (PATIENT'S) LIPS.