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	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented with numerous cellulite depressions, some in close proximity to one another.The cellulite depressions were treated with aveli.Lipo 360 and fat grafting were also performed in other areas.The patient presented with seromas on both buttocks and an area in the buttocks described as "separation or detached feeling" approximately 2 weeks post procedure.The patient has been using compression as directed.On both buttocks hundreds of cc's of fluid were drained (total) over 3-4 follow-up visits.The last visit was about 80 cc's total from both buttocks.Ultrasound at the last visit confirmed the fluid was gone after the last draining.

• 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: 17301983
• Report Number: 3020889437-2023-00005
• Device Sequence Number: 14409806
• Product Code: OUP
• UDI-Device Identifier: 00850036790006
• UDI-Public: 0850036790006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221336
• 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): 07/11/2023

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: 04/17/2025
• Device Catalogue Number: AVE001
• Device Lot Number: 23041701
• 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: 06/19/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 68 KG