MAUDE Adverse Event Report: ZELTIQ COOLSCULPTING

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Weight Changes (2607)

Event Date 02/11/2016

Event Type  Injury  

Event Description

I am writing to complain about zeltiq's coolsculpting procedure after having an adverse result.I believe that the equipment used is fda approved.I had the procedure in (b)(6) in (b)(6) 2016.Several months later, i started gaining fat around the area treated instead of seeing a reduction in adipose tissue.I went back to the provider and they have been documenting my complaint.They refunded my money and put a claim into zeltiq based on my complaint.There is a tv advertising promoting the use of coolsculpting.Recently i went to a plastic surgeon in (b)(6) and they performed liposuction on my abdomen to correct the issue.Several nurses in the office and my surgeon commented that they are hearing about adverse reactions to coolsculpting, but it appears the company is only interested in tracking the most rare side effect pah.I think that more should be done to protect consumers from thinking this product is safe.Zeltiq coolsculpting equipment used by (b)(6).

• Brand Name: COOLSCULPTING
• Type of Device: COOLSCULPTING
• Manufacturer (Section D): ZELTIQ
• MDR Report Key: 6303516
• MDR Text Key: 66731849
• Report Number: MW5067671
• Device Sequence Number: 1
• Product Code: OOK
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NONE.
• Patient Age: 55 YR
• Patient Weight: 71