MAUDE Adverse Event Report: REVELLE AESTHETICS, INC. AVELI

Model Number	AVE001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented with depressions of medium average depth and moderate laxity.Patient had flank and lateral thigh liposuction one year prior.Seven depressions were treated: one left posterior thigh; one left lateral thigh; one right buttock; four right lateral thigh.It was reported that the patient developed a seroma on the right lateral thigh after her procedure.The physician drained the seroma 4 times.The total volume drained was 25cc 1st time, 10cc 2nd time, 10cc 3rd time, 5cc final time.At approximately one month post procedure, the patient reported she's pleased with her outcome and the seroma wasn't a bother at all.She did follow post op protocol and wore compression pants 1 week post op.At two months post procedure the patient is doing well.There is no pain or discomfort but there is still some discoloration/bruising and hardness in the area.The patient indicated that the area looks and feels good but some dimples remain visually in photos.

• 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; 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: 15395211
• Report Number: 3020889-2022-00005
• Device Sequence Number: 12306787
• Product Code: OUP
• UDI-Device Identifier: 00850036790006
• UDI-Public: 00850036790006
• 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
• Report Date (Section B): 09/09/2022

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: 06/17/2023
• Device Model Number: AVE001
• Device Catalogue Number: AVE001
• Device Lot Number: 22061701
• 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: 08/15/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White