REVANESSE LIPS+ (WITH LIDOCAINE)

Description of Event or Problem

THE INJECTOR'S REPORT: "THE PATIENT,IS AN OFFICE STAFF MEMBER AND WAS TREATED ON (B)(6) 22 ,WITH 1.2ML OF REVANESSE LIPS. THE PATIENT RECENTLY DEVELOPED LITTLE BUMPS AROUND HER LIPS AND THE TOP LIP WAS SWOLLEN. INJECTOR AND MEDICAL DIRECTOR HAVE BEEN CHATTING AND THEY DON'T THINK THIS IS A REACTION FROM THE FILLER. APPARENTLY PATIENT WAS HAVING SOME ISSUES LAST WEEK WITH SWEEPING & HIVES ON HER WHOLE FACE, NOT JUST HER LIPS. SHE DID GO TO URGENT CARE TODAY AND THEY SAID SHE HAD AN INFECTION IN HER EYE SO IT MAY HAVE BEEN A SERIES OF THINGS CAUSING INFLAMMATION/BUMPS ON HER LIPS." MEDICAL DIRECTOR ALSO STATED "IT LOOKS LIKE SHE IS INFLAMED DIFFUSELY, NOT SURE THE LIPS. IT SEEMS UNLIKELY THAT THIS WOULD BE A DELAYED ALLERGIC REACTION" MEDICAL DIRECTOR STATED HE RECOMMENDED THE PATIENT SEE HER DOCTOR REGARDING THE INFECTION AND DIRECTED THAT IN THE MEANTIME, THE PATIENT COULD TRY ANTIHISTAMINE." MANUFACTURER HAS REACHED OUT TO THE CLINIC FOR ADDITION INFORMATION, NO RESPONSE WAS RECEIVED TO DATE.

Additional Manufacturer Narrative

THE PRODUCT LOT NUMBERS HAVE BEEN VERIFIED AND HAVE BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO OTHER CLINICAL COMPLAINTS WERE FOUND ASSOCIATED WITH THIS LOT NUMBERS. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYZED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES.