REVANESSE VERSA+ 1.0 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 WILL BE PROVIDED TO THE CLINIC: "THE FOLLOWING CLINICAL OPINION IS BASED ON THE HISTORY AND PHOTOS PROVIDED BY THE PHYSICIAN INJECTOR; ON (B)(6) 2021 THE PATIENT REQUESTED AND RECEIVED 2 SYRINGES OF REVANESSE VERSA+ INJECTED INTO HER LIPS. SHE WAS SEEN AT 3 WEEKS FOR FOLLOW UP. THE PATIENT WAS UNHAPPY WITH HER LIPS CLAIMING THEY WERE SWOLLEN AND THAT SHE HAD A SMALL SORE IN HER MOUTH. SHE HAD BEEN SEEN AND TREATED BY HER FAMILY DOCTOR FOR AN URI. SHE HAS A HISTORY OF COLD SORES, USUALLY OCCURRING ON HER EXTERNAL LIPS. SHE WAS SEEN IN FOLLOW UP BY THE INJECTING PHYSICIANS WHO SAW NO SIGNS OR SYMPTOMS OF A FILLER ADVERSE EVENT. SHE WAS THEN REFERRED TO AN INTERNIST WHO DOCUMENTED NO SIGNS OF A FILLER AE. THE PHOTOGRAPHS PROVIDES SHOW NO ERYTHEMA, NO INFLAMMATION, NO SWELLING AND NO LUMPS. THERE WERE 2 PHOTOS THAT SHOW 2 TINY CRACKS ON THE INNER MOUTH MUCOSA THAT LINED UP PERFECTLY WITH THE PATIENT DENTAL APPLIANCE ( ? FRONT LOWER TEETH BRIDGE ). THESE CRACKS WERE NOT ON THE LIP MUCOSA AND COULD ONLY BE SEEN WITH THE LIP TOTALLY EVERTED OUT OF THE PICTURE. MY CLINICAL OPINION BASED ON THE HISTORY, PHOTOS AND OPINIONS OF 3 EXAMINING PHYSICIANS IS THAT THERE IS NO SIGN NOR EVIDENCE OF ANY ADVERSE EVENT RELATED TO LIP FILLER. I TRUST THIS CLINICAL OPINIONS IS OF VALUE TO ALL PARTIES CONCERNED."

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE CLINIC, IN (B)(6) 2021 - DATE OF TREATMENT WITH TWO FULL SYRINGES OF REVANESSE VERSA+ 1.2 ML IN THE LIPS AREA OF THE PATIENT. MEDICAL DIRECTOR HAS BEEN INFORMED OF ADVERSE EVENT. PRODUCT NAME VERSA, LOT NUMBERS 20G069 X2. DATE OF TREATMENT (B)(6) 2021. PATIENTS AGE IS 45 AND CAUCASIAN. HAS HAD FILLER TREATMENT IN PAST, DID NOT PROVIDE TYPE, JUST STATED A FEW YEARS AGO. FITZPATRICK -1-2. THIS PATIENT DENIES HAVING HAD COVID AND HAS HAD, ACCORDING TO PATIENT, 7 NEGATIVE TESTS FOR COVID. SHE ALSO HAS NOT HAD COVID VACCINE. SHE SAID SHE HAD BEEN SICK BECAUSE SHE WAS EXPOSED TO MOLD. PMH: PATIENT REPORTS ON TOPOMAX FOR SEIZURES AND HAS MIGRAINE HEADACHES. SHE ALSO HAS ANXIETY DISORDER, PTSB AND BIPOLAR DISORDER. 1 SYRINGE OF FILLER WAS INJECTED INTO PATIENTS LIPS AND SHE REQUESTED A SECOND SYRINGE WHICH WAS INJECTED. PATIENT REPORTS THAT AFTER TREATMENT SHE DEVELOPED SOME NUMBNESS, TINGLING AND SWELLING AFTER THE PROCEDURE AND CALLED TO REPORT THESE SYMPTOMS. INJECTOR ASKED HER TO RETURN TO OFFICE FOR FOLLOW UP. PATIENT HAD NO BRUISING AND VERY MINIMAL SWELLING. INJECTOR ADVISED TO CONTINUE ICING AND SEE HER IN TWO WEEKS. AT 3 WEEKS APPOINTMENT, MONDAY (B)(6) 2021, PATIENT REPORTED SOME SORES IN MOUTH AND PERSISTENT NUMBNESS AND SOME KNOTS IN UPPER LIP, COUGHING, REDNESS AND IRRITATION OF THROAT, AND SOME SORES IN MOUTH. PATIENT WENT TO PRIMARY CARE PHYSICIAN WHO GAVE HER A ZPAK ANTIBIOTIC, AN ORAL MOUTH WASH FOR PAIN AND SHE WAS TAKING BENADRYL, WHICH SHE REPORTED DID NOT HELP HER SYMPTOMS. ON PHYSICAL EXAM ON THAT VISIT PATIENT HAD NO VISIBLE SWELLING OF HER LIPS, A COUPLE SMALL SORES IN HER MOUTH THAT WERE NONDESCRIPT. NO DISTINCT NODULARITY IN THE LIPS WAS PALPATED. FILLER WAS PRESENT BUT SOFT. INJECTOR HAD AN INTERNIST ALSO EXAMINE HER. INJECTOR PRESCRIBED HER VALTREX IN CASE THIS COULD BE A SMALL HERPES OUTBREAK, CHLORHEXIDINE AND A MEDROL DOSE PACK. PATIENT REPORTED NO IMPROVEMENT IN SYMPTOMS AND INSISTED INJECTOR TO DISSOLVE THE FILLER. PATIENT CAME IN (B)(6) 2021 AND INJECTOR TREATED HER WITH A VIAL OF HYALURONIDASE IN HER UPPER AND LOWER LIPS. PATIENT DID WELL WITH THE TREATMENT WITH NO SIDE EFFECTS. PATIENT HAS ASKED TO BE REIMBURSED FOR THE FILLER. INJECTOR NOT CHARGE HER FOR ANY FOLLOW UP VISITS OR THE HYALURONIDASE TREATMENT. PATIENT STATES SHE IS STILL NOT 100% RECOVERED YET. NOTE: INITIAL REPORT INCLUDED LOT#21D153 AS A SUSPECT MEDICAL DEVICE, HOWEVER, INJECTOR PROVIDED CORRECT LOT - 20G069. THIS LOT WAS SUBMITTED IN FOLLOW UP REPORT.

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. QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES HAS TRIED TO REACH MEDICAL DIRECTOR OF THE CLINIC MULTIPLE TIMES IN PAST 30 DAYS SINCE ADVERSE EVENT NOTIFICATION, HOWEVER, NOT ENOUGH INFORMATION IS PROVIDED. THUS, FURTHER INVESTIGATION WILL BE CONTINUING ONCE CLINIC PROVIDED ENOUGH DATA. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WILL BE PROVIDED TO THE CLINIC ONCE INVESTIGATION WILL BE COMPLETED.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE CLINIC, IN (B)(6) 2021 - DATE OF TREATMENT WITH TWO FULL SYRINGES OF REVANESSE LIPS+ 1.2 ML IN THE LIPS AREA OF THE PATIENT. APPROXIMATELY THREE WEEKS AFTER, ON (B)(6) 2021, PATIENT THOUGHT SHE IS HAVING AN ALLERGIC REACTION. PATIENT CAME TO THE CLINIC SAYING THE LIPS WERE SWOLLEN. PATIENT HAS BEEN DEALING WITH HOARSENESS AND COUGHING. INJECTOR ALSO REPORTED NUMBNESS AND TINGLING. VALTREX AND ANTIBIOTICS HAVE BEEN TAKEN AS REPORTED BY INJECTOR. MEDICAL DIRECTOR HAS BEEN INFORMED OF ADVERSE EVENT. AS REPORTED BY INJECTOR, PATIENT HAS PREVIOUSLY HAD FILLER WITH 1 FULL SYRINGE. INJECTOR HAS REPORTED THAT PATIENT HAS HISTORY OF ALLERGIES AND A HEAVY SMOKER. IT IS ALSO REPORTED THAT PATIENT HAD A TINY ULCER INSIDE OF MOUTH AND DID HAVE HERPES AS OF (B)(6) 2021.