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	Local Reaction (2035); Seroma (2069); Fibrosis (3167)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2023 that a patient treated with avéli on (b)(6) 2023 developed a seroma on the buttock and a seroma on the thigh.The seromas were drained by a healthcare provider successfully.Ultrasound confirmed there is no residual fluid.It was also reported that there is a firm lump on the buttock that the patient and physician can palpate but is not visible on the skin surface.The course of action is to have the patient continue to massage the lump and observe whether it gets smaller before considering an injection or other course of action to reduce it.
Event or Problem Description
It was reported on may 22, 2023 that a patient treated with avéli on (b)(6) 2023 developed a seroma on the buttock and a seroma on the thigh.The seromas were drained by a healthcare provider successfully.Ultrasound confirmed there is no residual fluid.It was also reported that there is a firm lump on the buttock that the patient and physician can palpate but is not visible on the skin surface.The course of action is to have the patient continue to massage the lump and observe whether it gets smaller before considering an injection or other course of action to reduce it.On 9/22/2023 it was reported that the patient presented with fibrosis in the area of the recurrent seroma.The physician is considering the use of a topical tripeptide/hexapeptide product in combination with cross or transverse friction massage to address the fibrosis.

• 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: 17135967
• Report Number: 3020889437-2023-00004
• Device Sequence Number: 6021247
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: 03/08/2025
• Device Catalogue Number: AVE001
• Device Lot Number: 23030701
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 68 KG