REVANESSE VERSA+ 1.2 ML

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML INTO THE UNSPECIFIED AREAS OF THE PATIENT ON (B)(6) 2022. HOWEVER, THE INJECTOR USED THE PRODUCT IN THE TEAR TROUGHS AND AT THE CORNERS OF THE MOUTH, PER REPORT OF THE PATIENT. AMOUNT OF PRODUCT INJECTED IS UNKNOWN, ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE; DATE OF BIRTH: UNSPECIFIED; AGE OF THE PATIENT: (B)(6). ACCORDING TO THE INITIAL REPORT, MONTHS AFTER INITIAL INJECTION, THE PATIENT CALLED FOR A CONSULTATION WITH A DOCTOR APPROXIMATELY IN (B)(6) 2022, WHO REPORTED THE EVENT TO PROLLENIUM MEDICAL TECHNOLOGIES, AFTER THE PATIENT STARTED EXPERIENCING SYMPTOMS REGARDING THE DERMAL FILLER TREATMENT THE PATIENT HAD ON (B)(6) 2022 AT A DIFFERENT PLACE WITH A DIFFERENT INJECTOR WHO IS ALLEGED TO BE A RN. DOCTOR IN CONSULTATION, WHO REPORTED THIS EVENT TO PROLLENIUM MEDICAL TECHNOLOGIES IS NOT AN INJECTOR. DOCTOR IN CONSULTATION SAW THE PATIENT AFTER THE EVENT. DOCTOR IN CONSULTATION WAS UNABLE TO ASCERTAIN HOW MUCH FILLER WAS USED INITIALLY. PROLLENIUM MEDICAL TECHNOLOGIES WAS ABLE TO OBTAIN THE NAME OF THE ALLEGED INJECTOR AND LOCATION OF PLACE OF INJECTION. THE INJECTOR AND THE PLACE OF INJECTION ARE NOT RECOGNIZED AS CUSTOMERS OF PROLLENIUM MEDICAL TECHNOLOGIES. THERE ARE NO RECORDS OF THIS OR ANY OTHER LOT OF DERMAL FILLERS MANUFACTURED BY PROLLENIUM MEDICAL TECHNOLOGIES BEING SOLD TO THE ALLEGED INJECTOR OR ALLEGED PLACE. THE INFORMATION ON WAYS THE PRODUCT WAS PURCHASED IS CURRENTLY BEING INVESTIGATED INTERNALLY. ACCORDING TO THE REPORT FROM THE DOCTOR IN CONSULTATION, THE PATIENT SUSTAINED DRAMATIC BRUISING IN THE BILATERAL TEAR TROUGHS, WORSE ON THE LEFT THAN RIGHT. THE FILLER WAS PALPABLE RIGHT UP INTO THE INNER CANTHUS AND THE PATIENT WAS OBSERVED TO HAVE TEARS RUN DOWN THE FACE RATHER THAN DRAINING THROUGH HER TEAR DUCT. PATIENT ALSO COMPLAINED OF WAKING IN THE MORNING WITH CRUSTED TEARS ON HER EYELASHES AND FACE. DOCTOR IN CONSULTATION INJECTED 2 VIALS OF HYALURONIDASE WITH SOME IMPROVEMENT IN THE OVER-ABUNDANT FILLER. THE PATIENT DID FOLLOW UP IN THE OFFICE ABOUT A WEEK LATER AND REPORTED A RETURN TO NORMAL FUNCTION OF HER TEAR DUCTS AND WAS NO LONGER OBSERVED TO HAVE TEARS CONTINUOUSLY STREAMING DOWN HER FACE. THE DISCOLORATION UNDER THE EYES DID NOT IMPROVE. DOCTOR IN CONSULTATION SUSPECTS THIS WILL BE PERMANENT TO SOME DEGREE. PHOTOS OF EVENT THAT ARE TAKEN BY PATIENT AND DOCTOR IN CONSULTATION AT THE OFFICE ARE PROVIDED. DOCTOR IN CONSULTATION ALSO REACHED OUT TO THE NORTH CAROLINA BOARD OF NURSING TO REPORT THE INJECTOR. IN THE OPINION OF THE DOCTOR IN CONSULTATION, THIS ADVERSE EVENT WAS 100% RELATED TO THE USE OF REVANESSE VERSA + BUT DOCTOR DOES NOT BELIEVE THE FILLER ITSELF WAS TO BLAME. DOCTOR BELIEVES THIS WAS DUE TO IMPROPER INJECTION TECHNIQUE AS PERFORMED BY AN INSUFFICIENTLY TRAINED AND UNSUPERVISED NURSE. AS REPORTED, A PATIENT'S PAST MEDICAL HISTORY IS SIGNIFICANT FOR HYPERTENSION AND DIABETES. PAST SURGICAL HISTORY IS REMARKABLE FOR CHOLECYSTECTOMY, BREAST REDUCTION, AND AN ORTHOPEDIC PROCEDURE ON RIGHT KNEE. MEDICATIONS INCLUDE METFORMIN, OZEMPIC, LISINOPRIL, PROTONIX, AND ZOLOFT. PATIENT TAKES NO ASPIRIN, ANTI-PLATELET AGENTS, OR BLOOD THINNERS. ELEVATED FITZPATRICK SCALE OF 2 REPORTED. NO ALLERGIES TO DERMAL FILLERS REPORTED. PATIENT IS REPORTED TO BE A FIRST TIME DERMAL FILLER TREATMENT.

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT IS BEING INVESTIGATED. THE LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO OTHER CLINICAL COMPLAINTS WERE FOUND ASSOCIATED WITH THIS LOT NUMBER. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES. PROLLENIUM MEDICAL TECHNOLOGIES WAS ABLE TO OBTAIN THE NAME OF THE ALLEGED INJECTOR AND LOCATION OF PLACE OF INJECTION. THE INJECTOR AND THE PLACE OF INJECTION ARE NOT RECOGNIZED AS CUSTOMERS OF PROLLENIUM MEDICAL TECHNOLOGIES. THERE ARE NO RECORDS OF THIS OR ANY OTHER LOT OF DERMAL FILLERS MANUFACTURED BY PROLLENIUM MEDICAL TECHNOLOGIES BEING SOLD TO THE ALLEGED INJECTOR OR ALLEGED PLACE. THE INFORMATION ON WAYS THE PRODUCT WAS PURCHASED IS CURRENTLY BEING INVESTIGATED INTERNALLY.