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	Easy Bruising (4558)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On april 30, 2024, a patient received 1.2 cc of revanesse versa+ injected into their lips.Compounded 23% lidocaine with 7% tetracine was applied to the lips prior to injection.The patient was also on usinopril ace inhibitor for the treatment of hypertension.There were no concerns or adverse events documented at the time of injection.Photos provided showed bruising in both lips however there was more bruising in the upper lip.Five (5) hours later the patient had moderate swelling in their upper lip.There was no pain, no nodules or other clinical concerns.The patient was given zyrtec and one dose of methylprednisolone and the symptoms completely resolved.The ha product was not dissolved.My clinical opinion is that this represents angioedema of the upper lip triggered by the combination of lip trauma (bruising) and ace inhibitor, which is well documented.Tetracaine is also the most allergenic topical anesthetic and could be a contributing factor.The lower lip did not swell ( ha was injected in both lips) and the reaction subsided despite the filler not being dissolved.In my opinion this excludes ha from being the cause of the "allergic reaction".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: 19552797
• Report Number: 3004423487-2024-00010
• Device Sequence Number: 20515725
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/31/2024

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: 02/07/2025
• Device Model Number: 40083
• Device Lot Number: 23B063
• 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: 05/01/2024
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• 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
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Race: White