MAUDE Adverse Event Report: REVELLE AESTHETICS, INC. AVELI

Catalog Number	AVE001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Necrosis (1971); Local Reaction (2035); Pressure Sore/Ulcer (2326); Localized Skin Lesion (4542)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient had a tummy tuck, lipo 360, and avéli procedures on (b)(6) 2022.At about 4-6 weeks post procedure, the patient came in for follow-up and there was a small dark black scab on the lateral left buttock.The small black eschar was indurated but not infected at 6 weeks.The treating physician advised the patient to take pressure off the area and it was reported that they expected the wound to heal.About 3 months post avéli procedure, the patient returned for follow-up and at this point the or nurse and treating physician reported the area of concern as "grossly infected, an abscess." it was reported that the wound required debridement, fat necrosis was found in the area underneath the wound, and the patient would likely need a surgery to address the volume loss.The treating physician reported that the wound was near the boney prominence of the ischium and is consistent with a pressure wound.The patient returned for follow up two months after the wound debridement and it was reported that the wound bed is healing well.
Additional Manufacturer Narrative
The report was originally sent on 11/3/2022, but with an incorrect report number; so this report is a resubmission.The original report number was 3020889-2022-00009 instead of 3020889437-2022-00009.
Event or Problem Description
It was previously reported that a female patient developed a wound requiring debridement following a tummy tuck, lipo 360, and avéli procedures.Fat necrosis was found in the area underneath the wound, and the patient would likely need a surgery to address the volume loss.The treating physician reported that the wound was near the boney prominence of the ischium and is consistent with a pressure wound.The patient returned for follow up two months after the wound debridement and it was reported that the wound bed is healing well.On (b)(6) 2023, the treating physician provided an update regarding the patient.It was reported that the patient's fat necrosis on the left buttock is healing well.The opening in the skin is smaller and is now several millimeters wide.It was reported that the patient still has some areas of firmness on the right buttocks and is returning to the office twice per week for massage to break up the areas of firmness.For future cosmetic improvement, the physician is planning 2-3 treatments with sculptra® over several months on both the left and right buttocks to fill the volume deficiency after the fat necrosis on the left side and to soften the right side.

• Brand Name: AVELI
• Common Device Name: AVELI
• Manufacturer (Section D): REVELLE AESTHETICS, INC.; 2570 w el camino real ste 310; mountain view CA 94040
• Manufacturer (Section G): REVELLE AESTHETICS, INC.; 2570 w el camino real ste 310; mountain view CA 94040
• Manufacturer Contact: melissa viotti ; 2570 w el camino real ste 310; mountain view, CA 94040 ; 6504720300
• MDR Report Key: 16236456
• Report Number: 3020889437-2022-00009
• Device Sequence Number: 6475203
• Product Code: OUP
• UDI-Device Identifier: 00850036790006
• UDI-Public: 0850036790006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2023
• Device Catalogue Number: AVE001
• Device Lot Number: 22011803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White