AVELI
Received Apr 1, 2024 · Event occurred Mar 4, 2024
Report 3020889437-2024-00002 · MDR key 19016503
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
42 YR · Female
- Ecchymosis
- Seroma
- Subcutaneous Nodule
- Ecchymosis
- Seroma
- Subcutaneous Nodule
Narrative
Description of Event or Problem
IT WAS REPORTED THAT 22 CELLULITE DEPRESSIONS WERE TREATED WITH AVELI, AND, APPROXIMATELY 4 WEEKS AFTER THE PROCEDURE, 30 CC'S OF FLUID WERE DRAINED FROM A SEROMA ON THE BUTTOCKS. IT WAS REPORTED THAT THREE DAYS LATER, 25 CC'S OF FLUID WERE DRAINED FROM A LARGER SEROMA ON THE BUTTOCKS, AND A FEW SMALL AREAS WERE DRAINED ON THE POSTERIOR SIDE. NODULES WERE ALSO REPORTED AND ARE DISSIPATING WITH MASSAGE AS OF ONE MONTH POST PROCEDURE. SIGNIFICANT BRUISING WAS REPORTED ON DAY 2 AFTER THE AVELI TREATMENT. COMPRESSION GARMENTS WERE WORN FOR TWO WEEKS AFTER THE PROCEDURE. THE BRUISING IS REPORTED TO BE ONGOING APPROXIMATELY ONE MONTH AFTER THE PROCEDURE.