inforMED
InjuryOUP

AVELI

Received Apr 22, 2025 · Event occurred Mar 14, 2025

Report 3020889437-2025-00001 · MDR key 21886973

Device

Generic name

Aveli

Catalog number

AVE001

Lot number

NC84223001

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

60 YR · Female

  • Seroma
  • Seroma

Narrative

Description of Event or Problem

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.