Description of Event or Problem · 0
BASED ON THE INFORMATION/REPORT PROVIDED BY THE INJECTOR,(B)(6),NP, THE PATIENT, A 38 YEARS OLD CAUCASIAN FEMALE, WAS INJECTED ON (B)(6) 2022 WAS INJECTED WITH LYFT IN CHEEKS AND THEN INJECTED REVANESSE LIPS+ (WITH LIDOCAINE), PN40149 LOT 21K057, IN UPPER AND LOWER LIP (0.5 IN UPPER AND 0.6 IN LOWER). TOPICAL ANESTHETIC, BENZOCAINE 21%/LIDOCAINE 8%/TETRACAINE 40%, WAS USED. PATIENT HAD MINIMUM SWELLING (E2338) IMMEDIATELY AFTER THE INJECTION. 2 HOURS AFTER INJECTION, PATIENT STARTED HAVING SIGNIFICANT SWELLING (E2338). TREATED WITH BENADRYL 50 MG IM WITH SOME IMPROVEMENT. WAS STARTED ON A MEDROL DOSE PACK. PATIENT DID NOT EXPERIENCE PAIN OR PRURITUS DURING THE EPISODE. SWELLING (E2338) SUBSIDED AND WAS CONSISTENT WITH EXPECTED SWELLING WITHIN 12 HOURS. NO FURTHER ISSUES OCCURRED AND HEALING PROCESS WAS OTHERWISE NORMAL. PATIENT HISTORY INCLUDES A COVID VACCINE OVER 12 MONTHS PRIOR TO INJECTION. NO KNOWN ALLERGIES TO MEDICATIONS OR FOOD ALLERGIES. SHE DOES HAVE A HISTORY OF COLD SORES AND WAS GIVEN PREVENTIVE VALTREX. NO OTHER RECENT MEDICATIONS. PATIENT RECEIVED 2 SYRINGES OF RESTYLANE LYFT IN THE CHEEKS DURING THE SAME PROCEDURE WITH NO REACTION. PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONTACTED (11-OCT-2022;18-OCT-2022;24-OCT-2022; 31-OCT-2022) THE CLINIC TO GET MORE INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT BUT HAVE GOT NO RESPONSE. THE INCOMPLETE INFORMATION WAS SUBMITTED TO PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR AND HE SUGGESTED MORE INFORMATION IS REQUESTED THROUGH PHONE CALL. ACCORDINGLY, PROLLENIUM MEDICAL TECHNOLOGIES CALLED THE INJECTOR ON 31-OCT-2022 AND SHE SENT THE REQUESTED INFORMATION ON 01-NOV-2022. THE NEW INFORMATION PROVIDED BY THE INJECTOR, WAS SUBMITTED TO PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR TO BE REVIEWED ON 01-NOV-2022 AND HE PROVIDED HIS OPINION ON 02-NOV-2022 AS FOLLOWS: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION AND PHOTOS PROVIDED BY THE CLINIC IN CASE (B)(4). ON (B)(6) 2022 A 38 YO FEMALE PATIENT RECEIVED RESTYLANE LYFT IN HER CHECK AND NLFS FOLLOWED BY REVENESSE LIPS + INTO HER UPPER AND LOWER LIPS. SHE HAS A HISTORY OF COLD SORES SO WAS ON VALTREX PRE INJECTION. PRIOR TO THE INJECTIONS HIGH DOSE COMPOUNDED TOPICAL ANESTHETIC WAS APPLIED TO INJECTION AREAS INCLUDING THE THIN EPITHELIUM AND MUCOSA OF THE LIPS. THERE WAS NO ISSUES OR CONCERNS AT THE TIME OF INJECTIONS. APPROXIMATELY 2 HOURS AFTER THE INJECTIONS THE PATIENT DEVELOPED SWELLING OF HER LIPS. SHE WAS TREATED WITH BENADRYL AND STARTED ON MEDROL DOSE PACK. THE SWELLING SUBSIDED WITHIN HOURS AND DID NOT RETURN. NONE OF THE FILLER WAS DISSOLVED AND THE FILLER AREAS DID NOT SWELL OR DEVELOP INFLAMMATION OR LUMPS. THIS PATIENT EXPERIENCED ANGIOEDEMA OF THE LIPS WHICH IS USUALLY CASED BY DRUGS OR FOODS. IN THIS CASE THERE ARE FOUR AGENTS THAT COULD HAVE POTENTIALLY CAUSED THIS EVENT. 1. COMPOUNDED HIGH DOSE TRIPLE ANESTHETIC TOPICAL. THESE CONSISTED OF 40% TETRACAINE, 21% BENZOCAINE AND 8% LIDOCAINE IN A TRANSDERMAL CARRIER BASE TO ENHANCE ABSORPTION INTO THE BODY. 2. VALTREX. 3&4 TWO DIFFERENT HA FILLERS. OF CLINICAL NOTE IS THE FACT THAT NOT ALL AREAS OF HA INJECTION SWELLED AND THE SWELLING DID NOT RETURN DESPITE THE HA REMAINING IN PLACE. THE MOST LIKELY CAUSATIVE AGENTS WOULD BE THE HIGH DOSE COMPOUNDED TOPICAL ANESTHETIC. IT IS OF NOTE THAT BENZOCAINE IS THE MOST ALLERGENIC ANESTHETIC AS IT IS AN ESTER. THERE HAS ALSO BEEN AN INCREASE OF REPORTED ALLERGIC REACTIONS TO ANESTHETICS. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS AN ANGIOEDEMA ALLERGIC REACTION TO HIGH DOSE TOPICAL ANESTHETICS APPLIED TO THE LIPS. THE REACTION RESOLVED IN KEEPING WITH THE DRUGS BEING ELIMINATED FROM THE BODY. I HOPE THIS CLINICAL OPINION WILL BE OF VALUE TO ALL PARTIES CONCERNED." INTERNAL REPORT NUMBER: (B)(4).