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

Model Number	40083
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Contact Dermatitis (4546)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a patient received 1.2 cc of revanesse versa+ into her lips and marionette lines.Topical anesthetic was applied, before the injection, to these same areas.There is no history of what post procedure products were being applied to the areas.There were no concerns or adverse events at the time of injection.Five weeks later the patient notified the injector that two days after the injections she experienced "irritated flaky skin" over her marionette lines.There was no reaction on the lips.The patient was seen at a walk-in-clinic and treated with steroids.It was not reported if this was oral or topical steroids.No clinic diagnosis was provided.There was no history of nodules or vascular compromise.After the steroid treatment was completed the flaky skin reoccurred, so the injecting physician dissolved the product in the marionettes with hylenex.My clinical opinion is that this case represents a contact dermatitis or perioral dermatitis.These are usually caused by products applied to the skin.The fact that there were no inflammatory nodules or skin reactions on the lips makes it less likely that the ha filler was the source of the patient's flaky skin.Internal report number: (b)(4).

• Brand Name: REVANESSE VERSA+ 1.2 ML
• Common Device Name: REVANESSE VERSA+
• 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: 20523374
• Report Number: 3004423487-2024-00022
• Device Sequence Number: 18418353
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160042 S004
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: 06/01/2024
• Device Model Number: 40083
• Device Lot Number: 22F065
• 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: 09/26/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2022
• 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: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White