AVELI
Received Aug 30, 2024 · Event occurred Aug 6, 2024
Report 3020889437-2024-00004 · MDR key 20112568
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
51 YR · Female
- Unspecified Infection
- Seroma
- Unspecified Infection
- Seroma
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN AVÉLI PATIENT HAD SIGNIFICANTLY MORE SWELLING/BRUISING ON HER LEFT SIDE COMPARED TO HER RIGHT SIDE IMMEDIATELY AFTER THE AVÉLI PROCEDURE. AT TWO WEEKS POST PROCEDURE THE PATIENT REPORTED ONGOING SWELLING AND BRUISING AND THAT HER THIGHS WERE VERY PAINFUL, HOT AND BURNING. THE PATIENT REPORTED A "LARGE DEFORMITY" ON HER LEFT THIGH. PATIENT REPORTED THAT HER RIGHT THIGH HAD AN AREA THAT WAS RED AND INFLAMED. THE SYMPTOMS WERE DIAGNOSED BY THE PHYSICIAN TO BE A LIKELY INFECTED SEROMA. PATIENT WAS ADVISED TO WEAR COMPRESSION GARMENTS AND WAS PRESCRIBED ANTIBIOTICS. IT WAS REPORTED THAT THE AREA RESOLVED.