Description of Event or Problem · 0
DATE OF TREATMENT: ON (B)(6) 2022. DATE OF THE ADVERSE EVENT REPORTING TO THE COMPANY (PROLLENIUM): ON (B)(6) 2022 (8 DAYS AFTER THE INJECTION). PRIOR TO INJECTION, THE PATIENT STATED SHE HAD HER LIPS DONE AT AN MD OFFICE OVER A YEAR AGO WITH JUVEDERM, AND AT THE TIME SHE EXPERIENCED A FAIR AMOUNT OF SWELLING THE DAY AFTER AND THEY ATTRIBUTED IT TO THE TOPICAL ANESTHETIC THEY USED. WHEN SHE CAME ON (B)(6)2022, SHE STATED SHE HAD A SENSITIVITY TO THE TOPICAL AND WANTED HER LIPS DONE WITH NO TOPICAL. ON THE DAY OF INJECTION, THE CLINIC USED SOME ICE AND THE PATIENT AGREED SHE WANTED A FULL SYRINGE MOSTLY IN THE LIPS AND SOME TO THE MARIONETTE LINES. THE INJECTOR USED REVANESSE LIPS+, FENCING TECHNIQUE AND BETWEEN THE BOTTOM AND TOP, USING A TOTAL OF 0.8 WITH A 31-GAUGE NEEDLE. THEN, WITH A 27-25MM CANNULA, THE INJECTOR USED THE BALANCE 0.2 ON EACH MARIONETTE LINE TO SOFTEN THEM. SHE HAD NO BRUISING. A FEW HOURS LATER, SHE SENT HER INJECTOR A TEXT WITH A PICTURE THAT SHE WAS INDEED SWELLING. SHE HAD TAKEN BENADRYL WHEN SHE FIRST STARTED NOTICING SOME SWELLING WITHIN THE FIRST 2 HOURS BUT BY 6PM IT WAS WORSE WHICH IS WHEN SHE CALLED AND SENT THE CLINIC THE PICTURE. THE CLINIC ASKED HER TO COME IN. SHE HAD NO SOB OR OTHER SYMPTOMS EXCEPT FOR THE LOCAL REACTION. SHE ALSO SWELLED WHERE SHE WAS INJECTED WITH A CANNULA THE MARIONETTE AREAS. THE CLINIC IMPLEMENTED A PREDNISONE PROTOCOL FOR MORE OF AN ALLERGY RESPONSE SHE TOOK A 40 MG LOADING DOSE AND STARTED THE MEDROL DOSE PACK THE FOLLOWING MORNING. SHE WAS NOT SURE IF SHE IS ALLERGIC TO THE PRESERVATIVE OR LIDOCAINE. SHE WAS CHECKED ON, 12 THEN 24 HOURS LATER, AND SHE WAS CONTINUING TO IMPROVE. QA SUPPORT AT PROLLENIUM MEDICAL TECHNOLOGIES LATER SENT AN EMAIL TO THE CLINIC AND LET THEM KNOW THAT THERE IS NO PRESERVATIVES OF ANY KIND IN PMT PRODUCTS. PROLLENIUM'S MEDICAL TECHNOLOGIES INC. HAD REQUESTED ITS OWN MEDICAL DIRECTOR'S OPINION AND HIS REVIEW IS DETAILED BELOW: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE: (B)(4). ON (B)(6) 2022 A 42 YO FEMALE RECEIVED 0.8 CC OF REVANESSE LIPS+ (WITH LIDOCAINE) INJECTED INTO HER UPPER AND LOWER LIPS AS WELL AS 33% OF THE SAME PRODUCT INJECTED INTO HER MARIONETTE LINES. THE PATIENT HAD A KNOWN AND DOCUMENTED ALLERGY TO TOPICAL ANESTHETICS. MOST TOPICAL ANESTHETICS (90 + %) CONTAIN LIDOCAINE. ALL COMPOUNDED TOPICAL ANESTHETICS CONTAIN HIGH DOSE LIDOCAINE. THE PATIENT'S MOTHER WAS ALSO ALLERGIC TO LIDOCAINE. NO BEFORE OR IMMEDIATELY AFTER PHOTOS WERE PROVIDED. A "FEW" HOURS LATER THE PATIENT CONTACTED THE CLINIC COMPLAINING OF SWELLING IN ALL AREAS INJECTED. SHE WAS TREATED WITH BENADRYL AND MEDROL DOSE PACK WHICH COMPLETELY RESOLVED THE SWELLING. THE SWELLING DID NOT RETURN AND THE FILLER WAS NOT DISSOLVED. THIS IMPLIES THE SWELLING WAS NOT RELATED TO THE HA FILLER. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS AN OBVIOUS ALLERGIC REACTION TO LIDOCAINE IN A PERSON WHO HAS AN ALLERGY TO LIDOCAINE. THIS PATIENT SHOULD HAVE RECEIVED HA FILLER WITHOUT LIDOCAINE, WHICH TECHNICALLY WOULD MAKE THIS A MEDICATION ERROR. I TRUST THIS CLINICAL OPINION WILL BE OF VALUE TO ALL PARTIES CONCERNED." INTERNAL REPORT NUMBER: (B)(4).