InjuryOUP
AVELI
Received Jan 16, 2024 · Event occurred Dec 18, 2023
Report 3020889437-2024-00001 · MDR key 18522328
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
42 YR · Female
- Hematoma
- Seroma
- Hematoma
- Seroma
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT COMPLETED THE AVELI PROCEDURE ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT PRESENTED WITH A SEROMA AND HAD APPROXIMATELY 35 CC OF CLEAR RED FLUID REMOVED. THE PHYSICIAN REPORTED THAT LIPOSUCTION WAS ALSO PERFORMED IN THE AREA AND THAT THE LIPOSUCTION COULD HAVE CONTRIBUTED TO THIS ADVERSE EVENT.