REVANESSE LIPS+ 1.2 ML

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT GOT INJECTED WITH 1.2 ML OF REVANESSE LIPS+ (WITH LIDOCAINE) INTO THE LIPS, ORAL COMMISSURES, LOWER NL FOLD AREA OF THE PATIENT ON (B)(6) 2022. PATIENT IS (B)(6) FEMALE CAUCASIAN. DOB- (B)(6) 1984 ACCORDING TO THE INJECTOR, THE PATIENT DENIES MEDICAL PROBLEMS, NKDA, NO NON-MEDICATION ALLERGIES INCLUDING SEASONAL, AND THE PATIENT ONLY TAKES ORAL CONTRACEPTIVE PILLS. PATIENT HAD COVID IN (B)(6) 2022. PATIENT WAS FULLY VACCINATED IN (B)(6) 2020. AS PER INITIAL REPORT, THE PATIENT CONTACTED THE CLINIC TO INFORM RN THAT THE PATIENT'S LIPS WERE "UNEVEN." PATIENT INSTRUCTED TO COME IN FOR EVALUATION. PATIENT PRESENTED ON (B)(6) 2022 WITH EDEMA IN LIPS AND PALPABLE NODULES THAT WERE NOT PRESENT IMMEDIATELY POST-INJECTION NOR IN WEEKS 2-4. PATIENT IMAGES OF INTERMITTENT SWELLING DATE BACK TO (B)(6) 2022. PATIENT DENIES ALLERGIES, IMMUNIZATIONS, ILLNESS, MEDICATIONS OTHER THAN OCPS. MEDICATIONS AFTER OR BEFORE THE TREATMENT: PATIENT TOOK 10-20 MG OF HER OWN PREDNISONE 2-3 TIMES BEFORE PRESENTING TO THE OFFICE FOR ASSESSMENT. 1 MEDROL DOSEPAK WAS PRESCRIBED TO PATIENT ON (B)(6) 2022 AFTER IN OFFICE ASSESSMENT BY DR. AND RN. PATIENT REPORTED IMPROVEMENT UNTIL (B)(6) 2022 WHEN SHE CONTACTED RN TO INFORM THAT PATIENT'S LIPS WERE EDEMATOUS ONCE AGAIN. PATIENT STATES THAT SHE TOOK 10 MG OF PREDNISONE ON (B)(6) 2022. PATIENT IS IN THE CLINIC ON (B)(6) 2022 FOR TX WITH HYALURONIDASE. FOLLOW UP WAS PLANNED LATER IN TWO WEEKS. AS PER INJECTOR, PATIENT HAS USED ICE INTERMITTENTLY, HYALURONIDASE, PREDNISONE AS DESCRIBED ABOVE, MEDROL DOSEPAK, FAMOTIDINE AND ZYRTEC INTERMITTENTLY, NO ABS, NO NSAIDS PER PATIENT REPORT. 23/7 LIDOCAINE TETRACAINE TOPICAL FROM EMPOWERRX WAS USED AS TOPICAL ANAESTHETIC. NO PREVIOUS DERMAL FILLER TREATMENTS REPORTED. NO KNOWN DRUG ALLERGIES REPORTED. NO ALLERGIES TO DERMAL FILLER REPORTED. ELEVATED FITZPATRICK SCALE OF 2 REPORTED. THE MEDICAL DIRECTOR OF THE CLINIC HAS BEEN NOTIFIED OF THIS ADVERSE EVENT AND INVOLVED IN MANAGEMENT OF THE ADVERSE EVENT.

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 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 WAS PROVIDED TO THE CLINIC ALONG WITH THE LETTER INDICATING APPROVED AREAS FOR INJECTION FOR REVANESSE LIPS+ PRODUCT: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED BELOW FROM THE CLINIC; ON (B)(6) 2022 THE PATIENT RECEIVED 1.2 MLS OF REVANESSE LIPS+ INJECTED INTO THE VERMILLION AND BODY OF THE LIPS, THE LOWER NLF AND THE ORAL COMMISSURES. COMPOUNDED LIDOCAINE & TETRACAINE TOPICAL ANESTHETIC WAS APPLIED TO THE AREA PRIOR TO INJECTION. THERE IS NO REPORTED HISTORY OF PAST MEDICAL HISTORY OR ALLERGIES. IT IS OF NOTE THAT THE PATIENT HAD AND TOOK " HER OWN PREDNISONE " 2-3 TIMES BEFORE BEING REASSESSED BY THE CLINIC. APPROXIMATELY 6 WEEKS POST INJECTION THE PATIENT CONTACTED THE CLINIC BECAUSE HER LIPS WERE " UNEVEN" OR ASYMMETRIC. THIS ASYMMETRY WAS PRESENT ON A PHOTO DATED (B)(6) 2022, 2 DAYS POST INJECTION. THE DATE THE PATIENT WAS REASSESSED AT THE CLINIC WAS NOT PROVIDED HOWEVER A PRESCRIPTION FOR MEDROL DOSE PACK WAS GIVEN (B)(6) 2022. THERE ARE ALSO UNDATED PHOTOS SHOWING ASYMMETRIC EDEMA ON THE LEFT BODY OF THE LIP. BASED ON THE CLOTHING AND SURROUNDING THESE PHOTOS APPEAR TO BE IMMEDIATELY POST TREATMENT (B)(6) 2022. THERE IS NO HISTORY OR PHOTOS SHOWING SWELLING OF THE VERMILLION BORDER, NLF OR ORAL COMMISSURES. THERE ARE NO PHOTOS SHOWING NODULES OR LUMPS. ON (B)(6) 2022 THE PATIENT CONTACTED THE NURSE INJECTOR REPORTING THAT SHE HAD ASYMMETRIC EDEMA IN HER LIPS. THE PATIENT TOOK ONE DOSE OF HER OWN PREDNISONE FOR THIS. THERE ARE NO PHOTOS OR ASSESSMENTS OF THIS EVENT. AT SOME POINT AFTER THIS THE PATIENT WAS SEEN AT THE CLINIC FOR INJECTION OF HYALURONIDASE AND PLANS WERE MADE TO REASSESS IN TWO WEEKS ( EARLY (B)(6) 2022 ). ALTHOUGH THE HISTORY AND TIMING OF EVENTS ARE NOT CLEAR THE RECURRENT THEME APPEARS TO BE "UNEVEN" ASYMMETRIC LIPS WHICH WERE PRESENT IN PHOTOS THE DAY OF AND 2 DAYS POST TREATMENT. THIS IS NOT UNCOMMON POST LIP INJECTION ESPECIALLY IF THERE IS SWELLING FROM TRAUMATIC EDEMA AT THE TIME OF INJECTION. THE PHOTOS PROVIDED SUGGEST THAT THIS WAS THE CASE WITH THIS INJECTION. I DO NOT SEE EVIDENCE OF NODULES OR ALLERGIC REACTIONS IN THE DATA PROVIDED. IT IS OF NOTE THAT USING PREDNISONE BRIEFLY AND INTERMITTENTLY CAN ACTUALLY LEAD TO RECURRENT SYMPTOMS. AN ALLERGIC REACTION TO HA ,WHICH EXISTS NATURALLY IN OUR BODY IS STATICALLY RARE AND IF AND WHEN IT OCCURS IT WOULD BE EXPECTED IN ALL AREAS THE HA WAS INJECTED. THIS DID NOT OCCUR IN THIS PATIENT. THAT BEING SAID IF THE TREATING HEALTH CARE PROFESSIONALS FELT THIS WAS A POTENTIAL DIAGNOSIS THEY MUST REMOVE ALL THE HA WITH HYLURONIDASE. ASYMMETRIC SWELLING OF THE LIP CAN COMMONLY OCCUR FROM LOCALIZED ICING AND OR MASSAGING OF THE LIP WHICH CREATES TRAUMA AND HISTAMINE RELEASE. MY CLINICAL OPINION BASED ON THE DATA PROVIDED BY THE CLINIC IS THAT THIS REPRESENTS AN INADVERTENT ASYMMETRIC INJECTION OF FILLER INTO THE LIP. THIS PROBLEM MAY HAVE THEN BEEN EXACERBATED BY THE TREATMENTS THE PATIENT WAS SELF ADMINISTERING AT HOME ( ICE, MASSAGE, PREDNISONE). THE SOLUTION, THAT THE CLINIC IS NOW DOING, IS TO DISSOLVE THE PRODUCT IN THE AREA OF THE PATIENTS CONCERN AND THEN REASSESS THE SITUATION."