MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC REVANESSE LIPS+ 1.2 ML

Model Number	40149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 a patient received 0.75cc of revanesse lips+ into their lips.Prior to injection the patient received chlorhexadine mouth rinse and compounded lidocaine 23% + tetracaine 7% topical anesthetic applied to their lips and therefore into their mouth.The patient also had a lip injection with the same product in (b)(6) 2023 with no issues or adverse events.During the injection the injector felt that the lips "blanched" very easily and appeared "more irritated".These concerns resolved by the end of the injection and there was no concerns or adverse events at the end of appointment.The injector was confident that there was no "vascular occlusion".At a follow up visit 4 weeks later it was noted that the patients lips still "looked swollen".There was not pain, no angioedema or signs of allergic reaction, no nodules and no inflammation.The after photos show a lower lip that is similar in size and shape to the pre photo.The upper lip is filled to a size larger than the lower lip, which is not a natural or pre filler state.The vermillion border is not swollen or distorted and the lip creases / wrinkles are still present.Product can be seen thru the epithelium of the upper lip.There are no signs of edema or an allergic reaction.My clinical opinion is that this case does not represent an adverse event but rather an excessive volume correction of the lips.The excess volume may also have caused brief compromise of the vascular flow, which would cause the blanching seen at the time of injection.If the patient is concerned with the increased volume of the lips it can be easily corrected with hyaluronidase.Internal report number: (b)(4).

• Brand Name: REVANESSE LIPS+ 1.2 ML
• Common Device Name: REVANESSE LIPS+
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC; 138 industrial parkway n; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 18768853
• Report Number: 3004423487-2024-00001
• Device Sequence Number: 7739474
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/23/2024

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: 09/07/2024
• Device Model Number: 40149
• Device Lot Number: 22I088
• 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: 02/02/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2022
• 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
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White