AVELI
Report
- Report Number
- 3020889437-2022-00002
- Event Type
- Injury
- Date Received
- June 29, 2022
- Date of Event
- May 27, 2022
- Report Date
- July 24, 2023
- Manufacturer
- REVELLE AESTHETICS, INC.
- Product Code
- OUP
- UDI-DI
- 00850036790006
- PMA / PMN Number
- K221336
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORT WAS DELAYED DUE TO THE ELECTRONIC SIGNUP PROCESS.
IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEROMA IN THE BUTTOCK, OBSERVED BY THE TREATING PHYSICIAN DURING THE TWO-WEEK FOLLOW-UP APPOINTMENT AFTER THE PROCEDURE. THE PATIENT PRESENTED WITH SUPERFICIAL DEPRESSION DEPTH, MILD LAXITY, FITZPATRICK SKIN TYPE III. EIGHT DEPRESSIONS WERE TREATED ON THE RIGHT BUTTOCK. THE PATIENT WAS TREATED WITH PROFOUND® APPROXIMATELY 3-4 YEARS PRIOR. THE SEROMA WAS OBSERVED ON THE RIGHT BUTTOCK, 1" SUPERIOR AND 2" MEDIAL FROM THE GLUTEAL CREASE ENTRY POINT. THE SIZE OF THE SEROMA WAS ROUGHLY 2"X2" AND THE TOTAL VOLUME DRAINED VIA NEEDLE WAS 60ML. THE PATIENT WAS ADVISED TO WEAR A MEDICAL GRADE COMPRESSION GARMENT FOR ONE WEEK. AFTER ONE WEEK, THE PHYSICIAN ASPIRATED THE SEROMA WITH ½ THE VOLUME AS THE WEEK PRIOR.
IT WAS REPORTED PREVIOUSLY THAT THE PATIENT DEVELOPED A SEROMA IN THE BUTTOCK REQUIRING ASPIRATION. THE PHYSICIAN SUBSEQUENTLY REPORTED THAT THIS PATIENT, HIS SECOND PATIENT TREATED WITH AVÉLI, CONTACTED HIM BY TEXT MESSAGE. THE PHYSICIAN REPORTED THAT AT 3 MONTHS POST-PROCEDURE THE PATIENT HAD AN ULTRASOUND WITH NEGATIVE RESULTS. THE PATIENT COMPLAINED OF A "HUGE MASS" THAT WAS "COLD AND RED AND ALMOST BRUISE LIKE" ON THE RIGHT BUTTOCK WHEN DOING AN ACTIVITY OF SURFING. THE REPORT FROM THE PATIENT WAS BY TEXT MESSAGE. THE PHYSICIAN DID NOT SEE THE PATIENT IN PERSON BECAUSE SHE MOVED OUT OF THE AREA.
IT WAS REPORTED PREVIOUSLY THAT THE PATIENT DEVELOPED A SEROMA IN THE BUTTOCK REQUIRING ASPIRATION. THE PHYSICIAN SUBSEQUENTLY REPORTED THAT THIS PATIENT, HIS SECOND PATIENT TREATED WITH AVÉLI, CONTACTED HIM BY TEXT MESSAGE. THE PHYSICIAN REPORTED THAT AT 3 MONTHS POST-PROCEDURE THE PATIENT HAD AN ULTRASOUND WITH NEGATIVE RESULTS. THE PATIENT COMPLAINED OF A "HUGE MASS" THAT WAS "COLD AND RED AND ALMOST BRUISE LIKE" ON THE RIGHT BUTTOCK WHEN DOING AN ACTIVITY OF SURFING. THE REPORT FROM THE PATIENT WAS BY TEXT MESSAGE. THE PHYSICIAN DID NOT SEE THE PATIENT IN PERSON PREVIOUSLY BECAUSE SHE MOVED OUT OF THE AREA. ON (B)(6) 2023 REVELLE RECEIVED A FOLLOW-UP TEXT MESSAGE FROM THE TREATING PHYSICIAN. THE PATIENT RETURNED FOR FOLLOW-UP AND HAS A FIRM FIST SIZED AREA IN THE SUBCUTANEOUS TISSUE THAT IS PALPABLE ON EXAM. THE PHYSICIAN INJECTED KENALOG AND WILL BRING THE PATIENT BACK AGAIN EVERY FEW WEEKS FOR INJECTION AS NEEDED.
ON 7/14/23 THE PHYSICIAN SENT REVELLE FOLLOW-UP INFORMATION BY EMAIL. THE PHYSICIAN REPORTED THAT A PATIENT TREATED WITH AVÉLI IN MAY 2022 HAD A SEROMA POST OP ON THE LEFT BUTTOCKS, WHICH WAS DRAINED TWICE AND WENT AWAY. THE PATIENT STILL HAS A PALPABLE LUMP, VERTICAL OVER THE LEFT BUTTOCKS ABOUT 10 CM LONG, 3 CM THICK THAT SHE FEELS WHEN SHE SITS ON IT. THE PHYSICIAN CAN PINCH IT TO CONFIRM ITS PRESENCE. THE PATIENT IS COMPLETELY NUMB OVER THE VERTICAL LUMP AND IS HYPERPIGMENTED. THE PHYSICIAN IS TREATING WITH HYDROQUINONE AND STEROID INJECTIONS. AFTER TWO INJECTIONS MILD IMPROVEMENT WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1091757 | AVELI | CELLULITE RELEASE DEVICE | OUP | REVELLE AESTHETICS, INC. | AVE001 | 22021702 | 00850036790006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | Required Intervention |