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	03/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent aveli cellulite release of bilateral buttocks with a dense cluster, essentially on both sides with scattered smaller clusters laterally and inferiorly.It was reported that the aveli patient returned to the clinic at 2 weeks post procedure with fluid filled sacs in the bilateral buttocks in the area of cellulite septa release.Under local infiltration, the provider reported that they created a tunnel upwards to the inner connecting pockets of seroma.The tunnel was made larger and a sterile drain was placed along the subcutaneous tunnel and sutured into place to allow drainage.The right drainage stayed in place and that seroma was completely resolved at the time of drain removal on day 6.The left side had fallen out and had only a slight fluid collection.By day 8, the patient complained of a collection of fluid on the left side and some warmth.The patient returned to the clinic and the provider created a separate new tunnel from the gluteal crease up to the pocket and placed another penrose drain.The provider removed another 40 cc of fluid from that pocket.The patient has not reported any recurrence.

• 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: 21886973
• Report Number: 3020889437-2025-00001
• Device Sequence Number: 8162409
• Product Code: OUP
• UDI-Device Identifier: 00850036790006
• UDI-Public: (01)00850036790006(11)231020(17)251020(10)NC84223001
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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: 10/20/2025
• Device Catalogue Number: AVE001
• Device Lot Number: NC84223001
• 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: 04/02/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2023
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 66 KG