MAUDE Adverse Event Report: MERZ / ULTHERA, INC. CELLFINA SYSTEM; POWERED SURGICAL INSTRUMENT FOR IMPROVEMENT IN THE APPEARANCE OF CELLULITE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Pain (1994); Scar Tissue (2060); Distress (2329); Deformity/ Disfigurement (2360); Impaired Healing (2378); Swelling/ Edema (4577)

Event Date 03/31/2019

Event Type  Injury  

Event Description

After my cellfina procedure on (b)(6) 2018, several large lumps and bulges of scar tissue developed on my butt and thighs.The lumps stuck out right above the cellfina incision scars.Over the months and years it took to recover and as the swelling went down, the lumps became more prominent and my thighs became more apparently deformed and disfigured.Cellfina has deformed my butt and thighs as well as left me with pain in those areas.When pressed, there are painful pinches and tightness from the scar tissue lumps.The scar tissue has not healed over time, and still after over three years, the painful bulges remain.This terribly appears to be permanent damage and disfigurement.Doctors have said there is no way to undo the damage and any attempt to repair the damage is extraordinarily risky and costly.Cellfina claims to be an easy, minimally invasive procedure to help cellulite without much downtime; however, it took over a year to heal from the bruising, bleeding stains, wide scars and swelling.Also, the scar tissue lumps and deformities are permanent damage.The horrible side effects and ongoing struggles have caused me serious mental distress as well.Cellfina claims to help a women's image and confidence, but it has caused me immense and continual harm.Fda safety report id# (b)(4).

• Brand Name: CELLFINA SYSTEM
• Type of Device: POWERED SURGICAL INSTRUMENT FOR IMPROVEMENT IN THE APPEARANCE OF CELLULITE
• Manufacturer (Section D): MERZ / ULTHERA, INC.
• MDR Report Key: 13358735
• MDR Text Key: 284619567
• Report Number: MW5106986
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White