AVELI
Received Aug 22, 2025 · Event occurred Aug 4, 2025
Report 3020889437-2025-00004 · MDR key 22879920
Device
Generic name
Aveli
Manufacturer
Revelle Aesthetics, Inc.Catalog number
AVE001
Lot number
ALL ACTIONS HAVE BEEN COMPLETE
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
36 YR · Female
- Seroma
- Seroma
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN AVELI PATIENT PRESENTED AT ONE MONTH POST TREATMENT WITH RESIDUAL FLUID RETENTION AT THE TREATMENT AREA. THE PATIENT FOLLOWED INSTRUCTIONS FROM THE PROVIDER. THE PROVIDER EVALUATED THE FLUID RETENTION ON ULTRASOUND. THE PROVIDER REPORTED THAT THERE IS NO INDURATION AND/OR SIGNS OF INFECTION AT THE SITE, AND THAT THE PATIENT HAD A SIGNIFICANT AMOUNT OF CELLULITE. THE PROVIDER REPORTED THAT THEY DRAINED OUT ANY POST PROCEDURE FLUID AFTER THE TREATMENT. PATIENT WAS STARTED ON BROMALINE AND ARNICA. THE PROVIDER WAS ADVISED TO DRAIN THE SEROMAS AND INSTRUCT THE PATIENT TO WEAR COMPRESSION GARMENTS.