MAUDE Adverse Event Report: ZELTIQ ZELTIG COOLSCULPTING

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 10/11/2013

Event Type  Injury  

Event Description

Subject was treated with zeltiq coolsculpting device on (b)(6) 2013. Everything went well during his treatment and at 2 month follow up he was noted to have significant fat loss in the treated area. He completed the study on (b)(6) 2013 with no issues or problems. He contacted me on (b)(6) 2013 to report that he had noted increased fat in the treated love handle area. He was seen at our clinic on (b)(6) 2013 and determined to have increased fat growth (ie increased love handle size) in the treated area compared to his baseline (beginning of the study). He will need to have liposuction to have this extra fat growth removed. The liposuction will be done for cosmetic reasons only as this increased fat growth is not harmful to patient or to his health in any way. This very rare side effect has been seen before in other patients treated with this device and has already been reported to the fda by the manufacturer. We also informed the manufacturer (zeltiq) of this incident.

• Brand Name: ZELTIG COOLSCULPTING
• Type of Device: COOLSCULPTING
• Manufacturer (Section D): ZELTIQ; pleasanton CA 94588
• MDR Report Key: 3427250
• MDR Text Key: 21045839
• Report Number: MW5032367
• Device Sequence Number: 1
• Product Code: OOK

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/18/2013

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/21/2013
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No