MAUDE Adverse Event Report: ZELITIQ AESTHETICS, INC COOLSCULPTING; DERMAL COOLING PACK/VACUUM/MASSAGER

Device Problem Insufficient Information (3190)

Patient Problem Emotional Changes (1831)

Event Type  Injury  

Event Description

Developed pah.Paradoxical adipose hyperplasia from coolscuplting.Along with many other health conditions since then.My whole health was affected by this device mentally and physically.I had to stop working.I couldn't take care of my kids.The list goes on and on.This destroyed my life in every way possible.My whole appearance.My teeth decayed and i had to pay countless amounts of money to try to keep up with them.This needs to be banned! its disgusting that this machine is still out here and its also terrible that we are all suffering and not being heard.We all need help.Justice needs to be served.I cant list all my tests done because i have seen every specialist possible that i was "allowed" to see.I was diagnosed with lupus but i don't believe i have it.Bipolar disorder and i was not bipolar.I lost my mind and here i sit here everyday wondering if i will ever be the same person.If i will be able to pay my bills ever again.No one cares if i did and that's so sad.I was so full of life before receiving coolscuplting.It was done at a medspa and that surgeon who was supposed to be watching the esthetician that performed the non invasive procedure did not do his job.He treated me poorly when i approached his office about how huge i got.I looked like i was carrying triplets for 4 years.No one would listen to me.Hard masses of bulges in my stomach.I was dying and it shows in my photos and all the 100's of people that knew and still know me.I was only offered (b)(6) for a sign and release to keep my mouth shut through allergan (zeltiq) my reconstructive surgery costs me out of pocket (b)(6) plus all my aftercare as well.Totaling about (b)(6) and still going.I had to borrow this money to save my life to get this pah removed from my body.We all need help.Please someone help us all.This took 4 years of my life.Was completely healthy before all of this.Fda safety report id# (b)(4).

• Brand Name: COOLSCULPTING
• Type of Device: DERMAL COOLING PACK/VACUUM/MASSAGER
• Manufacturer (Section D): ZELITIQ AESTHETICS, INC
• MDR Report Key: 15067206
• MDR Text Key: 296343576
• Report Number: MW5110987
• Device Sequence Number: 1
• Product Code: OOK
• 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: 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Life Threatening; Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White