REVANESSE

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT GOT INJECTED WITH REVANESSE DERMAL FILLERS IN THE UNSPECIFIED AREA OF THE PATIENT IN (B)(6). THE LOT OF THE PRODUCT INJECTED WAS NOT PROVIDED AND, THEREFORE, NOT VERIFIED. AMOUNT OF PRODUCT INJECTED WAS NOT SPECIFIED. DATE OF BIRTH NOT PROVIDED. ACCORDING TO THE INITIAL COMMUNICATION, AFTER THE INITIAL INJECTION IS RED AGAIN PROCEDURE IN (B)(6), THE PATIENT "HAD IT INJECTED FOR REMOVAL IN (B)(6)". PATIENT WAITED TWO WEEKS AND "IT IS RED AGAIN." PATIENT HAS BEEN ON MEDICATION AND "IT IS VERY RED AT THE SITE OF INJECTION" DESPITE BEING ALMOST DONE WITH THE MEDICATION. PATIENT HAS SEEN THE DOCTOR AND THE DOCTOR WAS NOT CONCERNED BUT THE PATIENT WAS NERVOUS BECAUSE SHE PUT HER ON MEDICATION. NO INFORMATION REGARDING TOPIC ANAESTHETIC HAS BEEN PROVIDED. NO INFORMATION REGARDING ALLERGIES HAS BEEN PROVIDED. NO INFORMATION REGARDING MEDICAL HISTORY AND PRESENCE OF RISK FACTORS HAVE BEEN PROVIDED. SINCE THE DAY OF NOTIFICATION, THE QA DEPARTMENT HAS ATTEMPTED TO INVESTIGATE THE CLINIC AND INJECTOR INFORMATION. PATIENT WAS CONTACTED VIA THE EMAIL ADDRESS PROVIDED IN THE INITIAL REPORT, HOWEVER NO RESPONSE HAS BEEN RECEIVED. AS OF (B)(6) 2022, NO RESPONSE FROM THE PATIENT HAS BEEN RECEIVED. THE QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES HAS ALSO CONTACTED THE ALLEGED CLINIC SEVERAL TIMES SINCE THE DAY OF NOTIFICATION, HOWEVER, THE CLINIC HAS STATED THAT THEY DID NOT HAVE ANY PATIENT WITH REPORTED SYMPTOMS. ADDITIONALLY, THE CLINIC STATED THAT THEY WERE NOT AWARE OF ANYONE HAVING AN ISSUE WITH VERSA. THE QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES WILL CONTINUE THE INVESTIGATION.

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT IS IN THE PROCESS OF INVESTIGATION. THE LOT NUMBER HAS NOT BEEN VERIFIED DUE TO THE ABSENCE OF INFORMATION. IT WILL BE CONFIRMED WHETHER ANY CLINICAL COMPLAINTS HAVE BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION ONCE REQUESTED INFORMATION IS PROVIDED. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WILL BE ANALYSED AND BE DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES ONCE LOT IS VERIFIED. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WILL BE PROVIDED TO THE CLINIC ALONG WITH THE LETTER INDICATING APPROVED AREAS FOR INJECTION FOR REVANESSE VERSA+ AND REVANESSE LIPS+ PRODUCTS WHEN REQUESTED INFORMATION FOR CONDUCTING INVESTIGATION IS PROVIDED.