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	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient treated for cellulite with aveli subsequently developed a significant lump on the left thigh.Revelle learned on (b)(6) 2023 that the lump was diagnosed as a seroma and an unknown volume of fluid was drained.It was reported that the area is improving.
Event or Problem Description
It was previously reported that a patient treated for cellulite with aveli subsequently developed a significant lump on the left thigh.Revelle learned on 8/11/2023 that the lump was diagnosed as a seroma and an unknown volume of fluid was drained.It was reported that the area is improving.On 8/17/2023 revelle was provided additional information.On (b)(6) 2023 60 ml was drained from the seroma.One week later, an additional 30 ml was drained.
Additional Manufacturer Narrative
In the initial report, the patient information was not available.The age was estimated to be 42 years, the median age of the confirm participants.The patient weight was estimated to be 150 lbs, the median weight of the confirm participants.The corrected patient information is below: weight: 168lb.Age: 26 years old.Dob: (b)(6) 1996.Race/ethnicity: hispanic.

• 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: 17513315
• Report Number: 3020889437-2023-00008
• Device Sequence Number: 12146598
• Product Code: OUP
• UDI-Device Identifier: 00850036790006
• UDI-Public: 0850036790006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 08/23/2023

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: 05/09/2025
• Device Catalogue Number: AVE001
• Device Lot Number: 23050903
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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: 26 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Hispanic