REVANESSE LIPS+ (WITH LIDOCAINE)

Description of Event or Problem

PATIENT INFORMATION: NO INFORMATION WAS PROVIDED. ADVERSE EVENT INFORMATION: THE CLINIC REPORTED THAT THEIR PATIENT RECENTLY HAD LIPS DONE USING REVANESSE LIPS+. THE PATIENT STATES THEY ARE EXTREMELY BUMPY. IT HAS BEEN APPROXIMATELY 1 MONTH. NEW INJECTOR DID HER LIPS. THE CLINIC'S MEDICAL DIRECTOR IS INQUIRING IF THIS COULD BE MISPLACEMENT OR POSSIBLY THAT THE PATIENT OVER MASSAGED THEM AFTER THE FACT AND THE FILLER MOVED. OR COULD SHE BE HAVING A REACTION TO THE FILLER/INGREDIENTS? FOLLOW-UP COMMUNICATIONS WITH CLINIC: FOLLOWING RECEIPT OF THE INITIAL REPORT ON (B)(6) 2025, PROLLENIUM MEDICAL TECHNOLOGIES HAD REACHED OUT TO THE CLINIC ON (B)(6) 2025 FOR ADDITIONAL INFORMATION PERTAINING TO THE REPORTED ADVERSE EVENT. UPON NO RESPONSE FROM CLINIC, PROLLENIUM SENT ANOTHER FOLLOW UP EMAIL ON (B)(6) 2025. ON THE SAME DAY, THE SALES REPRESENTATIVE ADVISED THAT THE CLINIC WOULD NOT LIKE TO MOVE FORWARD WITH REPORTING AN AE AND ASKED TO CANCEL THE REQUEST. THE PROLLENIUM HOWEVER SENT ANOTHER EMAIL ON (B)(6) 2025 ATTACHING THE "NOTIFICATION REGARDING ADVERSE EVENT REPORTAGE" NOTE INQUIRING FOR MORE INFORMATION. RESULTS OF MEDICAL ASSESSMENT: ON (B)(6) 2025 A PATIENT RECEIVED REVANESSE LIPS+ INTO HER LIPS. " A NEW INJECTORS DID HER LIP". THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. NO PRE OR POST PHOTOS WERE PROVIDED. NO MEDICAL HISTORY OR PRE & POST ADDITIONAL TREATMENTS WERE PROVIDED. APPROXIMATELY ONE MONTH LATER THE PATIENT COMPLAINED TO THE CLINIC THAT HER LIPS FELT BUMPY. THERE WERE NO NODULES, NECROSIS OR INFLAMMATION DESCRIBED. THERE IS NO HISTORY OF A MEDICAL ASSESSMENT OR AN IN PERSON PATIENT ASSESSMENT. THE CLINIC LATER CALLED AND REQUESTED THAT THE MAUDE REPORT BE WITHDRAWN. "MY CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IS THAT THIS CASE DOES NOT REPRESENT AN ADVERSE EVENT. IT IS A CASE OF SUBOPTIMAL INJECTION THAT RESOLVED.IMDRF CODES INCLUDE A25 (NO APPARENT ADVERSE EVENT); B14(ANALYSIS OF PRODUCTION RECORDS), C23 (USAGE PROBLEM IDENTIFIED), D1002(ADVERSE EVENT RELATED TO PROCEDURE), E2005(EASY BRUISING), F1205(TEMPORARY IMPAIRMENT), AND G07001(PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE)."