REVANESSE

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.

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 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 INJECTOR STATED THAT SHE WAS UNSURE IF AN AREA TREATED HAS A BRUISE OR IF IT WAS A POSSIBLE VASCULAR OCCLUSION. 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 INJECTOR WAS CONTACTED VIA THE EMAIL ADDRESS PROVIDED IN THE INITIAL COMMUNICATION TO RETRIEVE INFORMATION REGARDING THE AE, HOWEVER NO RESPONSE HAS BEEN RECEIVED. THE QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES HAS ALSO CONTACTED THE ALLEGED INJECTOR SEVERAL TIMES SINCE THE DAY OF NOTIFICATION, HOWEVER, NO RESPONSE FROM THE INJECTOR HAS BEEN RECEIVED. AS OF 12 JULY 2022, NO RESPONSE FROM THE INJECTOR HAS BEEN RECEIVED. THE QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES WILL CONTINUE THE INVESTIGATION.