MAUDE Adverse Event Report: ZELTIQ AESTHETICS INC. ZELTIQ EZ APP 6.3 ZELTIQ VACUUM APPLICATOR

Model Number EZ APP 6.3

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/12/2011

Event Type  Injury  

Event Description

It is alleged that a (b)(6) male patient received two coolsculpting treatments on the lower abdomen with 6. 3 applicator on (b)(6) 2011. Three month post treatment follow up showed increased fat in the treated area. The physician retreated the patient on (b)(6) 2012. On (b)(6) 2012, the physician clarified that the tissue was firm before the second treatment but they were still able to complete the second treatment. Zeltiq made multiple attempts to contact the physician and patient between june and august without success. On (b)(6) 2012, zeltiq personnel visited the clinic and were able to meet with the physician and the patient on his four month follow up visit. The treatment area was still described to be firm. Zeltiq recommended diagnostic treating to which the patient agreed on (b)(6) 2012. On (b)(6) 2012, the patient underwent an ultrasound procedure. The report stated "increase in volume, thickness and density of the described lower abdominal fat not associated with collections or mass. There is no eventration. " on (b)(6) 2012, the patient was seen by a plastic surgeon who recommended liposuction procedure and therefore zeltiq is reporting this event. A follow-up report will be made to the agency if and when new information is received about this case.

Manufacturer Narrative

Zeltiq reviewed the system logs for both treatments and confirmed that no system malfunction occurred during both treatments. The clinical group followed up with the physician to collect additional information as it was unclear about the tissue consistency after the first treatment. The case was further complicated by the patient undergoing multiple pressure treatments (lymphatic drainage treatments) after the first coolsculpting treatment.

• Brand Name: ZELTIQ EZ APP 6.3
• Type of Device: ZELTIQ VACUUM APPLICATOR
• Manufacturer (Section D): ZELTIQ AESTHETICS INC.; 4698 willow road; pleasanton CA 94588
• Manufacturer Contact: gurvinder nanda ; 4698 willow road; pleasanton, CA 94588 ; 9254742500
• MDR Report Key: 2802334
• MDR Text Key: 3095126
• Report Number: 3007215625-2012-00014
• Device Sequence Number: 1
• Product Code: OOK
• Combination Product (Y/N): N
• Reporter Country Code: CO
• PMA/PMN Number: K080521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/12/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/19/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: EZ APP 6.3
• Device Catalogue Number: BRZ-AP1-063-000
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 10/12/2012
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/01/2011
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 10/19/2012 Patient Sequence Number: 1