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 Codes	Seroma (2069); Subcutaneous Nodule (4548)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A negative review of avéli was written on the realself.Com online forum for plastic surgery and cosmetic procedures.The alleged patient reported that they had the avéli procedure and complained of dimples, indentations, and hard lumps on the buttocks.The individual reported a "weird shape like a bad bbl" but they did not have a bbl.Another user commented on the post "hi, i would definetly not worry.Easier said than done but honestly it looks like you need to have your doctor drain your seroma.My butt looked saggy and heavy like that too when i wasn't wearing my compression shorts.Everything is mostly healed and smooth now, my butt is still firm and i'm massaging out nodules." the original poster replied "thank you! you were right! he drained it and already looks much better.I appreciate you!" the post was removed the next day from the website.

• 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: 19155321
• Report Number: 3020889437-2024-00003
• Device Sequence Number: 7477629
• 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: K232153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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 Catalogue Number: AVE001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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