AVELI
Received May 19, 2025 · Event occurred May 1, 2025
Report 3020889437-2025-00003 · MDR key 22048752
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
43 YR · Female
- Seroma
- Seroma
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WAS TREATED WITH AVÉLI TWO MONTHS AGO AND THE PATIENT DEVELOPED A 5CM X 2CM SEROMA ON THE LEFT LATERAL THIGH APPROXIMATELY ONE WEEK AFTER TREATMENT. IT WAS REPORTED THAT THE PHYSICIAN DRAINED APPROXIMATELY 5CC OF FLUID, AND NO SIGNS OR SYMPTOMS OF INFECTION WERE OBSERVED. THE PROVIDER HAS CONTINUED TO DRAIN THE SEROMA BIWEEKLY FOR A TOTAL OF FIVE PROCEDURES, REMOVING NO MORE THAN 5CC OF SEROSANGUINEOUS FLUID EACH TIME. THROUGHOUT THIS PROCESS, THERE HAVE BEEN NO INDICATIONS OF INFECTION. ADDITIONALLY, THE PROVIDER ADMINISTERED A DOXYCYCLINE GAVAGE ONE WEEK AGO, BUT THERE HAS BEEN NO NOTICEABLE REDUCTION IN THE SIZE OF THE SEROMA AS OF YESTERDAY. DR. (B)(6) WOULD LIKE CLINICAL SUGGESTIONS ON HOW TO RESOLVE THE SEROMA. HE ADMITTED THAT HE NEVER HAD THE PATIENT USE ANY TYPE OF COMPRESSION GARMENT POST PROCEDURE. ON 05/01/25, THE PHYSICIAN REPORTED VIA EMAIL THAT THE SEROMA DID NOT RESOLVE WITH MULTIPLE MODALITIES AND NEEDS TO BE SURGICALLY CLOSED NOW.