REVANESSE

Additional Manufacturer Narrative

SINCE THE DAY OF NOTIFICATION, THE PATIENT WAS CONTACTED VIA THE PHONE NUMBER PROVIDED IN THE INITIAL COMMUNICATION TO RETRIEVE INFORMATION REGARDING THE AE, HOWEVER NO RESPONSE HAS BEEN RECEIVED. AS OF 16 AUG 2022, NO RESPONSE FROM THE PATIENT HAS BEEN RECEIVED. ALLEGED CLINIC HAS ALSO BEEN CONTACTED BY THE QA DEPARTMENT SEVERAL TIMES, HOWEVER, NO RESPONSE REGARDING THIS EVENT HAS BEEN RECEIVED. 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.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT ALLEGEDLY GOT INJECTED WITH REVANESSE DERMAL FILLERS IN THE UNSPECIFIED AREA OF THE PATIENT ON AN UNSPECIFIED DATE. THE LOT OF THE PRODUCT INJECTED WAS NOT PROVIDED AND, THEREFORE, NOT VERIFIED. AMOUNT OF PRODUCT INJECTED WAS NOT SPECIFIED. PATIENT'S GENDER IS UNSPECIFIED. DATE OF BIRTH NOT PROVIDED. ACCORDING TO THE INITIAL COMMUNICATION, THE PATIENT CALLED PROLLENIUM'S CALL CENTRE WITH THE PURPOSE OF REPORTING A CLINICAL COMPLAINT. WHEN ASKED FOR SYMPTOMS, PATIENTS STATED "FACE DROOPING AND SEVERE SWELLING". PATIENT PROVIDED INFORMATION SUCH AS THE LAST NAME OF THE PATIENT; CONTACT EMAIL; CLINIC NAME WHERE THE PATIENT WAS ALLEGEDLY TREATED WHEN ASKED DURING INITIAL COMMUNICATION. PATIENT STATED THAT (B)(6) 2022 IS DAY 12 SINCE TREATMENT AND INITIALLY THEIR LEFT EYE GOT SWOLLEN AND IT CREATED A POCKET UNDER THEIR LEFT EYE. THEN, THE PATIENT WENT BACK AND GOT IT DISSOLVED A BIT BUT NOW THE RIGHT SIDE IS SWOLLEN AND IT IS THOUGHT THAT THE INJECTION WAS NOT PLACED RIGHT. PATIENT HAD SWELLING FOR 9 DAYS UNTIL THE DISSOLVER WAS PUT IN AND NOW THE POCKET IS LOOSE. ACCORDING TO THE PATIENT, IT LOOKS BETTER THAN IT DID BUT IT IS STILL SWOLLEN. THE PATIENT STATED TO WOULD LIKE TO KNOW HOW LONG THIS WOULD LAST BEFORE IT IS DECIDED TO GET MORE DISSOLVED. 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 PATIENT WAS CONTACTED VIA THE PHONE NUMBER PROVIDED IN THE INITIAL COMMUNICATION TO RETRIEVE INFORMATION REGARDING THE AE, HOWEVER NO RESPONSE HAS BEEN RECEIVED. AS OF 16 AUG 2022, NO RESPONSE FROM THE PATIENT HAS BEEN RECEIVED. ALLEGED CLINIC HAS ALSO BEEN CONTACTED BY THE QA DEPARTMENT SEVERAL TIMES, HOWEVER, NO RESPONSE REGARDING THIS EVENT HAS BEEN RECEIVED.