REVANESSE

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT ALLEGEDLY GOT INJECTED WITH REVANESSE DERMAL FILLER IN THE LIPS AREA OF THE PATIENT ON (B)(6) 2022. THE LOT OF THE PRODUCT INJECTED WAS NOT PROVIDED AND THEREFORE NOT VERIFIED. AMOUNT OF PRODUCT INJECTED WAS 0.4 ML. PATIENT'S GENDER IS FEMALE. DATE OF BIRTH IS (B)(6) 1990. ACCORDING TO THE INITIAL COMMUNICATION, THE PATIENT WAS INJECTED IN LIP AND ENDED UP WITH A 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 CLINIC WAS CONTACTED TO RETRIEVE INFORMATION REGARDING THE AE, HOWEVER NO RESPONSE HAS BEEN RECEIVED. AS OF (B)(6) 2022, NO RESPONSE FROM THE CLINIC HAS BEEN RECEIVED.

Additional Manufacturer Narrative

SINCE THE DAY OF NOTIFICATION, THE CLINIC WAS CONTACTED TO RETRIEVE INFORMATION REGARDING THE AE, HOWEVER NO RESPONSE HAS BEEN RECEIVED. AS OF (B)(6) 2022, NO RESPONSE FROM THE CLINIC 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.