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 FILLER THAT IS ALLEGED TO BE REVANESSE LIPS+(WITH LIDOCAINE), IN THE LIP SAREA 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 1 CC, ACCORDING TO THE INITIAL REPORT. PATIENT'S GENDER IS FEMALE. DATE OF BIRTH IS (B)(6) 1956. ACCORDING TO THE INITIAL COMMUNICATION, THE INJECTOR STATED THAT THE PATIENT RECEIVED DYSPORT IN GLABELLA AND REVANESSE LIPS+ IN THE LIPS AREA. PATIENT REPORTED HIVES ON HER BODY AFTER INJECTIONS OF THESE TWO PRODUCTS. AS PER REPORT, NOTHING KNOWN IF THE PATIENT ATE ANYTHING THAT COULD HAVE CAUSED THESE AFFECTS. . 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 AND MEDICAL DIRECTOR OF THE CLINIC HAS BEEN CONTACTED SEVERAL TIMES VIA THE EMAIL ADDRESS PROVIDED IN THE INITIAL COMMUNICATION TO RETRIEVE MORE INFORMATION REGARDING THE AE, HOWEVER NO RESPONSE HAS BEEN RECEIVED. AS OF (B)(6) 2022, NO RESPONSE FROM THE INJECTOR AND CLINIC HAS BEEN RECEIVED. THE QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES WILL CONTINUE THE INVESTIGATION.