REVANESSE

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT GOT INJECTED WITH REVANESSE DERMAL FILLER IN THE UNSPECIFIED AREA OF THE PATIENT ON AN UNSPECIFIED DATE. THE LOT OF THE PRODUCT INJECTED WAS NOT PROVIDED AND, THEREFORE, NOT VERIFIED. THE AMOUNT INJECTED IS 0.4 ML USING 25 G CANNULA. ACCORDING TO THE INITIAL COMMUNICATION, THERE WAS A BULGING OF TEAR TROUGHS. PATIENT EXPERIENCED FLUID FILLED BULGING. DATE OF BIRTH NOT PROVIDED. PATIENT'S GENDER IS NOT PROVIDED. 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 QA DEPARTMENT HAS ATTEMPTED TO CONTACT THE INJECTOR AND CLINIC MULTIPLE TIMES TO INQUIRE ADDITIONAL INFORMATION REGARDING THE EVENT, HOWEVER NO RESPONSE HAS BEEN RECEIVED. AS OF 14 JULY 2022, NO RESPONSE FROM THE CLINIC HAS BEEN RECEIVED. THE QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES WILL CONTINUE THE INVESTIGATION.

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.