REVANESSE

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT ALLEGEDLY GOT INJECTED WITH REVANESSE DERMAL FILLER IN THE UPPER AND LOWER 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 NOT SPECIFIED. PATIENT'S GENDER IS FEMALE. DATE OF BIRTH IS NOT PROVIDED. ACCORDING TO THE INITIAL COMMUNICATION, AT 3 WEEKS POST-INJECTION, PATIENT REPORTED SIGNIFICANT SWELLING IN BOTH LIPS. ON (B)(6) 2022, PROVIDER TREATED PATIENT WITH ICE, PIPCID AND CLARITIN, 10 MG DEXAMETHASONE SHOT AND STARTED A 10 DAY COURSE OF PREDNISONE. PATIENT WAS GETTING BETTER UNTIL 9/3, SENT PROVIDER MESSAGE THAT BOTTOM LIP WAS GETTING WORSE. NO PAIN, NO SIGNS OF INFECTION, NO SYSTEMIC BACTERIAL OR VIRAL INFECTION, NO RECENT VACCINE USE. 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 PATIENT 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.