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	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a bbl performed by another provider approximately 6 months before the avéli procedure for cellulite.During the pre-avéli consult the physician palpated and felt more than a dozen firm areas that he described as "oil cysts" or "fat necrosis" from the previous bbl procedure, primarily in the inferior buttocks.The avéli procedure was performed as normal, but during the expression of the anesthesia fluid at the end of the case, the physician observed oil from the entry site consistent with draining an oil cyst.The one-week post-avéli follow up was normal with no seroma observed.At approximately 5 weeks follow up the physician aspirated approximately 140cc of serous fluid from the inferior right buttocks.

• 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: 17836854
• Report Number: 3020889437-2023-00009
• Device Sequence Number: 7666736
• Product Code: OUP
• UDI-Device Identifier: 00850036790006
• UDI-Public: 0850036790006
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/27/2023

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: 06/05/2025
• Device Catalogue Number: AVE001
• Device Lot Number: NC82223A
• 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: 09/12/2023
• Initial Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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: 30 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Hispanic