MAUDE Adverse Event Report: REVELLE AESTHETICS, INC. AVELI

Catalog Number	AVE001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was treated with avéli two months ago and the patient developed a 5cm x 2cm seroma on the left lateral thigh approximately one week after treatment.It was reported that the physician drained approximately 5cc of fluid, and no signs or symptoms of infection were observed.The provider has continued to drain the seroma biweekly for a total of five procedures, removing no more than 5cc of serosanguineous fluid each time.Throughout this process, there have been no indications of infection.Additionally, the provider administered a doxycycline gavage one week ago, but there has been no noticeable reduction in the size of the seroma as of yesterday.Dr.(b)(6) would like clinical suggestions on how to resolve the seroma.He admitted that he never had the patient use any type of compression garment post procedure.On 05/01/25, the physician reported via email that the seroma did not resolve with multiple modalities and needs to be surgically closed now.

• Brand Name: AVELI
• Common Device Name: AVELI
• Manufacturer (Section D): REVELLE AESTHETICS, INC.; 2570 w el camino real ste 310; mountain view CA 94040
• Manufacturer (Section G): REVELLE AESTHETICS, INC.; 2570 w el camino real ste 310; mountain view CA 94040
• Manufacturer Contact: melissa viotti ; 2570 w el camino real ste 310; mountain view, CA 94040 ; 6504720300
• MDR Report Key: 22048752
• Report Number: 3020889437-2025-00003
• Device Sequence Number: 8990543
• Product Code: OUP
• UDI-Device Identifier: 00850036790006
• UDI-Public: (01)00850036790006(11)240513(17)260513(10)NC81924002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K232153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2025

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: 05/13/2026
• Device Catalogue Number: AVE001
• Device Lot Number: NC81924002
• 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: 05/01/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2024
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 68 KG