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	Cellulitis (1768); Hematoma (1884); Hyperemia (1904); Necrosis (1971); Local Reaction (2035); Seroma (2069)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Avéli has not been evaluated in combination with other procedures.The treating physician's name was not provided and therefore could not be reached for revelle's investigation.Revelle's medical director reviewed the photos provided by the patient and concluded that the condition observed in the photos provided is probable cellulitis, necrosis, seroma, or hematoma and is much more likely related to the underlying bbl than the use of avéli.
Event or Problem Description
A negative review of avéli was reported on the realself.Com online forum for plastic surgery.The alleged patient reported that they had the avéli procedure combined with brazilian butt lift (bbl).The patient wrote "avoid combined procedure they make it like it's the best it's terrible with a bbl , i got 3-degree burns, blow outs around the burns lumps i may have to deal with this for the rest of my life, discolored skin.I'm mortified please don't do it anyone thinking about it get the bbl first then maybe if u want to try, not together no one tell you the risks only the rewards.I can't even be naked in front of my husband without feeling ashamed.This is a nightmare procedure combined." revelle was able to contact the patient.The patient responded: "yea so, i had a bbl w aveli and the spots that aveli was used for dents cellulite developed blisters, which turned into burns so that's why i thought it had something to do with the and i did go to a double board-certified plastic surgeon and spent a lot of money.Traveled to huston lux recovery house i spent over 30k the doc said it was a combination on both.I have pictures." the patient provided photos and added: "so all the dots burns , are where the aveli was done i'm am 34 healthy non smoker.This was my mommy make over gone wrong smh.The blow out are from not contracting due to the damage it's not nercrois [sic] i had it checked.I'm going for a 3 m follow up in april i'm 2 months out." the patient also reported "it's so uncomfortable there's one spot that i got the aveli and it actually made a lump so when i sit on that lump, it's very uncomfortable.".
Event or Problem Description
This is a follow-up report with additional information received.A negative review of avéli was reported on the realself.Com online forum for plastic surgery on (b)(6) 2023.The patient contacted revelle again on (b)(6) , 2024 with updated information.The patient received avéli and fat grafting (bbl) in the buttocks, and approximately 18 months after the procedures she reported that she is experiencing scarring, pain, and bruising.The patient reported on realself.Com: "all the scars is where the aveli was used to take out the cellulite which left scarring aveli and bbl should not be done together, better training needs to take place so these things don't happen.I would like to contact the corporate office.".
Additional Manufacturer Narrative
Revelle's medical director reviewed updated photos provided by the patient and concluded that the condition much more likely related to the underlying bbl than the use of avéli.

• 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: 16588182
• Report Number: 3020889437-2023-00002
• Device Sequence Number: 19016382
• Product Code: OUP
• UDI-Device Identifier: 00850036790006
• UDI-Public: 0850036790006
• Combination Product (Y/N): N
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: 09/22/2024
• Device Catalogue Number: AVE001
• Device Lot Number: 22092203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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: Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White