MAUDE Adverse Event Report: ALLERGAN/ABBVIE IRELAND NL B.V. BALLYTIVNAN COOLSCULPTING; DERMAL COOLING PACK/VACUUM/MASSAGER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Deformity/ Disfigurement (2360); Abdominal Distention (2601)

Event Date 09/21/2021

Event Type  Injury  

Event Description

I had coolsculpting done on my upper and lower abdomen.It looked pretty good for 3-4 months and then literally overnight i woke up and my stomach had tripled in size.Large fat deposits in the shape of the coolsculpting applicator appeared exactly where they had been placed.The fat is dense, rubbery fibrous and very large.To have this happen to me has been nothing short of traumatizing.My stomach is completely disfigured.It's affected my mental health and is destroying my self esteem.I have seen 2 plastic surgeons they both have the same approach.To begin with, i require one liposuction treatment to each area.We will watch my recovery to see how that goes.I have been told that i could potentially require a second liposuction surgery to treat my issue.I'm addition to this, once i heal from above surgeries, i will need a 3rd surgery which is a full tummy tuck abdominoplasty.This surgery will require one month off work and i'm self employed therefore no income for a month.The tummy tuck is a very difficult recovery.I will end up with a scar from hip to hip for the rest of my life.The total cost for surgeries is (b)(6) and i've been offered (b)(6) in compensation from the company that owns coolsculpting.This has destroyed my body, my self esteem and my finances.They say it's a rare side effect but i believe it's under reported because have the "shame" attached to this problem.Fda safety report id# (b)(4).

• Brand Name: COOLSCULPTING
• Type of Device: DERMAL COOLING PACK/VACUUM/MASSAGER
• Manufacturer (Section D): ALLERGAN/ABBVIE IRELAND NL B.V. BALLYTIVNAN
• MDR Report Key: 15067183
• MDR Text Key: 296330389
• Report Number: MW5110985
• Device Sequence Number: 1
• Product Code: OOK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/16/2022

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Race: White