MAUDE Adverse Event Report: ZELTIQ COOLSCULPT; DERMAL COOLING PACK/VACUMN/MASSAGER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Discomfort (2330); Abdominal Distention (2601)

Event Date 05/09/2015

Event Type  Injury  

Event Description

Had cool sculpting on abdomen at (b)(6) performed by aesthetician.Told would result in removing fat cells w/o affecting skin.I returned 4 weeks later and said i felt my abdomen was bigger.I was told only her trained eye could see difference in volume.I filed complaint w/ (b)(4) on (b)(6) 2015 as my abdomen was getting hard with nodules and bigger.No weight gain happened.The (b)(4) informed me on 01/07/2016 they could not pursue the case as the business did not respond.Since this time i have had my abdomen become harder w/rippled skin and much discomfort.I feel the cool sculpt is to blame.

• Brand Name: COOLSCULPT
• Type of Device: DERMAL COOLING PACK/VACUMN/MASSAGER
• Manufacturer (Section D): ZELTIQ
• MDR Report Key: 6427208
• MDR Text Key: 70685904
• Report Number: MW5068580
• 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: 03/21/2017

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?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: MULTI; RX MEDS: AVA PRO HCTZ
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 73