MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Prollenium received the adverse event report on 04-apr-2024.Details below : the injector informs the manufacturer that she has had 5 patients that have bumps on the top upper lip occurring approximately 1 year after being injected.The patients age range was form 25 yrs to mid 40s's.These were all first time lip filler patients.All of these patients were injected around the same time and returning lip filler patients were not experiencing these reactions.Prollenium has completed multiple attempts to request the injector for details on each patient to evaluate the reports on a case-by-case basis.No response has been provided so far.Product name and lot number could not be confirmed.Prollenium has completed multiple attempts to reach out the clinic,no response has been provided so far.Prollenium shall provide the clinic with a 30 day notice letter.The investigation could not be adequately completed owing to the lack of information provided.

• Brand Name: REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML
• Common Device Name: REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway north; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC,; 138 industrial parkway north; aurora, on L4G4C 3; CA L4G4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway north; aurora, on L4G4C-3 ; CA L4G4C3
• MDR Report Key: 19241822
• Report Number: 3004423487-2024-00007
• Device Sequence Number: 12622381
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P160042 S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female