InjuryOUP
AVELI
Received May 19, 2025 · Event occurred Mar 31, 2025
Report 3020889437-2025-00002 · MDR key 22048576
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
42 YR · Female
- Seroma
- Seroma
Narrative
Description of Event or Problem
A PATIENT REPORTED THAT 4 WEEKS AFTER BEING TREATED WITH AVELI FOR CELLULITE ON (B)(6) 2025 THAT INSTEAD OF A DIMPLE SHE HAS A "RIDGE" ON HER BUTTOCKS. ON (B)(6) 2025, THE PATIENT PROVIDED ADDITIONAL INFORMATION: "I WORE THE COMPRESSION GARMENT FOR 4 WEEKS . THE FIRST 3 WEEK ALL THE TIME. I COULD FEEL IT 1 WEEK LATER AND IT WAS VISIBLE 2 WEEKS LATER. THE "RIDGE/ SEROMA" WAS DRAINED 2 WEEKS LATER." THE PATIENT REPORTED THAT AFTER MASSAGING THE AREA THE RIDGE IS STILL THERE BUT MIGHT HAVE GOTTEN A BIT SMALLER AND IS STILL VISIBLE AND PALPABLE.