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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Deformity/ Disfigurement (2360); Pulmonary Hypertension (4460)

Event Date 07/07/2020

Event Type  Injury  

Event Description

This is regarding coolsculpting - i have had 2 treatments on my abdomen and 1 treatment on my inner thighs and have been seriously disfigured due to this.The result is pah(pulmonary arterial hypertension).I have had to seek plastic surgery consults to correct this.This has caused mental anguish, and insecurities, and hindered my social life.I would like to pursue a lawsuit against abbvie.Reference reports: mw5117038, mw5117039.

• Brand Name: COOLSCULPTING
• Type of Device: DERMAL COOLING PACK / VACUUM MASSAGER
• Manufacturer (Section D): ZELTIQ AESTHETICS INC.
• MDR Report Key: 16816183
• MDR Text Key: 314126535
• Report Number: MW5117037
• 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: 04/22/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White