REVANESSE LIPS+ (WITH LIDOCAINE)

Description of Event or Problem

PATIENT INFORMATION: THE PATIENT IS A FEMALE, 23 YEARS OF AGE (DOB (B)(6) 1999), HISPANIC LIGHT IV WITH PRIOR HISTORY OF HERPES ON THE LIP AREA. MEDICAL HISTORY OF CELIAC DISEASE, GASTROPARESIS-BORDERLINE. PATIENT WAS PRESCRIBED ACYCLOVIR 800MG DAILY X7, TO START 2 DAYS PRIOR TO TREATMENT. CLINIC REPORTS THAT PATIENT HAS NOT TAKEN THE MEDICATION PRESCRIBED. CLINIC REPORTS PATIENT HISTORY OF NO PREVIOUS DERMAL FILLERS, NO ALLERGIES TO DERMAL FILLER TREATMENTS, ELEVATED FITZPATRICK SCALE 4 AND NO HISTORY OF ARTHRITIS. ADVERSE EVENT INFORMATION: BASED ON THE INITIAL INFORMATION PROVIDED BY THE CLINIC, THE PATIENT WAS INJECTED WITH REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML PN40149, LOT NUMBER 22E206 ON (B)(6) 2023 ON THE LIPS, VOLUME OF 1.0ML WAS INJECTED. THE PATIENT CAME FOR A TOUCH UP ON (B)(6) 2023. THE PATIENT STARTED TO DEVELOP LUMPS AND BUBBLES AT THE LOWER LIP ONE MONTH POST TREATMENT. THE LUMP POOLED WITH BLOOD A WEEK AGO AND FORMED A DRIED SCAB. PATIENT ALSO REPORTED TO THE INJECTOR THAT SHE HAD BUBBLES ON THE AREA OF RIGHT LIP. TOPICAL ANAESTHETIC WAS USED, NO DETAILS WERE PROVIDED. FOLLOW UP COMMUNICATIONS WITH CLINIC: FOLLOWING RECEIPT OF INITIAL REPORT ON THE 14-JUN-2023, MANUFACTURER HAS REACHED OUT TO THE CLINIC FOR ADDITION INFORMATION PERTAINING TO THE REPORTED ADVERSE INCIDENT. THIS INFORMATION IS REQUIRED FOR PROLLENIUM'S MEDICAL DIRECTOR TO MAKE A SUITABLE MEDICAL ASSESSMENT OF THE CASE PRESENTED. MONDAY, JULY 17, 2023 CLINIC HAS RESPONDED WITH THE REQUIRED INFORMATION.

Description of Event or Problem

PATIENT INFORMATION: THE PATIENT IS A FEMALE, F23 YEARS OF AGE, WITH PRIOR HISTORY OF HERPES ON THE LIP AREA. MEDICAL HISTORY OF CELIAC DISEASE, GASTROPARESIS-BORDERLINE. PATIENT WAS PRESCRIBED ACYCLOVIR 800MG DAILY X7, TO START 2 DAYS PRIOR TO TREATMENT. CLINIC REPORTS THAT PATIENT HAS NOT TAKEN THE MEDICATION PRESCRIBED. . ADVERSE EVENT INFORMATION: BASED ON THE INITIAL INFORMATION PROVIDED BY THE CLINIC, THE PATIENT WAS INJECTED WITH REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML PN40149, LOT NUMBER 22E206 ON (B)(6) 2023 ON THE LIPS, VOLUME OF 1.0ML WAS INJECTED. THE PATIENT CAME FOR A TOUCH UP ON (B)(6) 2023. THE PATIENT STARTED TO DEVELOP LUMPS AND BUBBLES AT THE LOWER LIP ONE MONTH POST TREATMENT. THE LUMP POOLED WITH BLOOD A WEEK AGO AND FORMED A DRIED SCAB. PATIENT ALSO REPORTED TO THE INJECTOR THAT SHE HAD BUBBLES ON THE AREA OF RIGHT LIP. FOLLOW UP COMMUNICATIONS WITH CLINIC: FOLLOWING RECEIPT OF INITIAL REPORT ON THE 14-JUN-2023, MANUFACTURER HAS REACHED OUT TO THE CLINIC FOR ADDITION INFORMATION PERTAINING TO THE REPORTED ADVERSE INCIDENT. THIS INFORMATION IS REQUIRED FOR PROLLENIUM'S MEDICAL DIRECTOR TO MAKE A SUITABLE MEDICAL ASSESSMENT OF THE CASE PRESENTED. THE INVESTIGATION IS ONGOING.