REVANESSE VERSA + (W/ LIDOCAINE) 1.2ML

Description of Event or Problem

TREATMENT INFORMATION: BASED ON THE INFORMATION PROVIDED BY THE CLINIC, THE PATIENT, FEMALE, AGE UNDISCLOSED, CAUCASIAN WAS INJECTED ON (B)(6) 2022 WITH REVANESSE VERSA + (W/ LIDOCAINE) 1.2ML PN40083; LOT NUMBER 21K089. THE INJECTOR, MEDICAL DOCTOR INJECTED ONE SYRINGE (1.2ML) TOTAL INTO THE UPPER AND LOWER LIPS. TOPICAL BLT (BENZOCAINE 20%, LIDOCAINE 10% AND TETRACAINE 10%) WAS USED PRIOR TO INJECTION. ADVERSE EVENT INFORMATION: ON (B)(6) 2022, THE PATIENT DEVELOPED 2 PUSTULES (BLISTER; E1703) ON THE LIPS AND MORE THE FOLLOWING DAY. PHOTOGRAPHS TAKEN ON (B)(6) 2022 HAVE BEEN PROVIDED TO THE MANUFACTURER. THE PATIENT WAS TREATED WITH ACYCLOVIR STARTING ON (B)(6) 2022 ALSO GIVEN PEPCID AC AND BENADRYL, TYLENOL FOLLOW UP COMMUNICATIONS WITH THE CLINIC:(B)(6) MEDICAL DIRECTOR HAS REQUESTED INFORMATION ON (1) ANY PAST MEDICAL HISTORY INCLUDING MEDICATIONS AND HISTORY OF COLD SORES OR RECENT VACCINES (2) WHICH DISINFECTANTS AND TOPICAL ANESTHETICS WERE USED. THE CLINIC REPORTED TO QA VIA A TELEPHONE CALL ON THE (B)(6) 2022, THAT NO INDICATION WAS PROVIDED TO CLINIC WITH REGARD TO HISTORY OF COLD SORES. QA HAS REQUESTED CLINIC FOR THE PATIENT RECORDS, NONE WAS PROVIDED. THE CLINIC REPORTED TO QA VIA A TELEPHONE CALL ON THE (B)(6) 2022 THE DETAILS OF DISINFECTANT AND TOPICAL USED. TREATMENT AREA WAS CLEANED WITH HIBICLENS ANTIMICROBIAL/ANTIBACTERIAL CLEANSER, CLINIC ALSO REPORTED USE OF SKINTEGRITY WOUND CLEANSER AS A DISINFECTANT. MANUFACTURER IS COLLECTING INFORMATION FOR A MEDICAL ASSESSMENT BY COMPANY MEDICAL DIRECTOR.

Description of Event or Problem

RESULTS OF MEDICAL ASSESSMENT:THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION AND PHOTO PROVIDED BY THE CLINIC IN CASE (B)(4). ON (B)(6) 2022, A FEMALE PATIENT HAD 1.2 CC OF REVANESSE VERSA+ INJECTED INTO HER LIPS. THE PATIENT HAD A KNOWN HISTORY OF CHRONIC GRANULOMATOUS DISEASE WHICH IS A RELATIVE CONTRAINDICATION TO ANY MEDICAL PROCEDURE THAT WOULD POTENTIALLY CAUSE INFECTION AS THIS CONDITION LIMITS A PATIENT'S ABILITY TO FIGHT INFECTION AND CAUSES A HIGHER RISK OF TISSUE GRANULOMAS. PRIOR TO THE PROCEDURE HIBICLENS DISINFECTANT WAS APPLIED TO THE LIPS AND COMPOUNDED BLT ( (B)(4)) TOPICAL ANESTHETIC WAS ALSO APPLIED TO THE LIPS. THERE WERE NO ISSUES AT THE TIME OF INJECTION. THREE DAYS LATER (B)(6) 2022, THE PATIENT CALLED THE CLINIC WITH CONCERNS OF 2 VESICLES ON HER LIPS. SHE WAS STARTED ON ACYCLOVIR, BENADRYL AND PEPCID AC. THE VESICLES RESOLVED AND THE PATIENT IS NOW FINE. MY CLINICAL OPINION IS THAT THIS PATIENT HAD A REACTIVATION OF PRE-EXISTING HERPES SIMPLEX VIRUS AND SHOULD HAVE BEEN STARTED ON SUPPRESSIVE THERAPY BEFORE INJECTION. AGAIN, THIS PATIENT WAS NOT A GOOD CANDIDATE FOR MEDICAL INJECTIONS DUE TO HER CHRONIC GRANULOMATOUS DISEASE. I HOPE THIS CLINICAL OPINION IS OF VALUE TO ALL PARTIES CONCERNED. THIS INFORMATION FROM THE MEDICAL DIRECTOR WAS COMMUNICATED TO THE TREATING PHYSICIAN.