inforMED
InjuryOUP

AVELI

Received Aug 30, 2024 · Event occurred Aug 6, 2024

Report 3020889437-2024-00004 · MDR key 20112568

Device

Generic name

Aveli

Catalog number

AVE001

Lot number

NC80524001

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.