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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Emotional Changes (1831); Pain (1994); Weight Changes (2607); Nodule (4551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2021

Event Type  Injury  

Event Description

I was an athletic 41 years old woman looking for eliminate some stubborn localized fat in my legs, and stomach when i bought a package of 16 sessions of coolsculpting.I wasn't informed about the risk of developing paradoxical adipose hyperplasia.Some weeks after receiving 10 out of the 16 applications i started to notice some painful and unexpected symptoms.Some knots start growing in my legs as well as pockets of hard fat, where i never had them before.Later i also realized my legs had an unusual shape, that changed my complete natural figure, it was if my entire body metabolic system was altered, and it was.So that i decided to not go for the second round of applications that were payed and i asked for an explanation directly with the provider (b)(6).They told me they had never had any case like mine and told me they will open a case with zeltiq.I preferred to take the case by myself, i visit a plastic surgeon who diagnosed me pah (paradoxical adipose hyperplasia).I was in shock, i started eating less, doing more and more exercises but nothing was enough, i still gaining weight and my legs were more and more deformed.Zeltiq finally admitted it was pah and asked me to sign a release in order to compensate me for the injuries.When i received their check (the one they gave me for my silence) i scheduled a reparative liposuction in all the areas previously treated with coolsculpting.At that moment also my abs where presenting irregularities.After 6 months post op i still have some knots in my thighs and they look completely deformed.I have what some professionals call "shark bites" what i suppose are frozen bites and they cannot be repaired easily.At the moment i cannot have a fat grafting because (i don't have the money) and (i don't have enough fat in my body).The quality of the fat that was removed from my body during liposuction was compromised, were bad fat cells and could not be used for grafting.Today the only existing resource that can partially reshape my thighs is a costly treatment called renuva, that consists in injections of a matrix that can gradually replaces fat loss with your body's own fat.But who will pay for it? besides all the months i have being physically suffering with this problems, they destroyed not only my body but my self-steam and my last two vacations.I'm not the same person anymore.I have being hidden from people, wearing baggy clothes.That machine took me two years of my life, and left me with a problem for life.Fda safety report id # (b)(4).

• Brand Name: COOLSCULPTING
• Type of Device: DERMAL COOLING PACK/VACUUM/MASSAGER
• Manufacturer (Section D): ZELTIQ AESTHETICS, INC.
• MDR Report Key: 15258486
• MDR Text Key: 298415030
• Report Number: MW5111591
• 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: 08/17/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Hispanic
• Patient Race: White