MAUDE Adverse Event Report: AIRSCULPT; LASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USE

Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Had a full abdominal liposuction with the new elite airsculpt device and 5 days later, i'm experiencing back pain and i have a huge protrusion/swelling at my lower abdomen that's also painful to touch.It also looks deformed.Was promised minimally invasive procedure with capability to return to work in just 2 days.That's not true.I'm hurting and it's not getting better and the site refuses to answer any questions about the procedure or what i should expect.The procedure was done at elite body sculpting and procedure by dr.(b)(6).Fda safety report id# (b)(4).

• Brand Name: AIRSCULPT
• Common Device Name: LASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USE
• MDR Report Key: 13196286
• Report Number: MW5106519
• Device Sequence Number: 1686235
• Product Code: PKT
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American