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

Model Number	PN40149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinic's account was sent on 26-apr-2024: "injected.8 in lips,.4 in chin, radiesse in jaw line and cheeks.Injected her on (b)(6).Everything was fine until she got on the cruise on thurs (b)(6) and on sunday (b)(6) she reached out to her injector and her lips were really swollen, painful and felt like there is little bb's in them.Injector prescribed a steroid pack.Took first dose yesterday and swelling is down today but still bumps." here's the clinical opinion by (b)(6) medical director", on 31-may-2024: "the following is a clinical response based on the information provided in case (b)(4).On (b)(6) 2024 a patient received revanesse lips+ into their lips and chin.Prior to injection hibiclens, alcohol, lidocaine, tetracaine and phenlyephrine were all applied to the lips.Radiesse was also injected into the patients' cheeks and jaw line.There were adverse events or clinical concerns at the time of injection.The patient went on a cruise on (b)(6) 2024 and on (b)(6) 2024, after being in the sun for three days, reported to their injector that their lips were swollen and they could feels tiny bumps.The chin, cheeks and jawline were not swollen.It was later diagnosed that the patient had a polymorphic light eruption reaction to the sun.My clinical opinion is that this case represents a reaction to intense sunlight and not an adverse event to ha fillers.".

• 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 n; aurora, on L4G 4 C3,; CA L4G 4C3,
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway north,; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 19471291
• Report Number: 3004423487-2024-00012
• Device Sequence Number: 7441858
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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
• Device Expiration Date: 11/17/2025
• Device Model Number: PN40149
• Device Lot Number: 23K176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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
• Patient Race: White