MAUDE Adverse Event Report: ZELTIQ AESTHETICS INC. ZELTIQ COOLCORE (6.3) ZELTIQ VACUUM APPLICATOR

Model Number COOLCORE APP (6.3)

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 04/04/2012

Event Type  Injury  

Event Description

It is alleged that a (b)(6) female patient received two coolsculpting treatment cycles with the coolcore (6. 3) applicator to the upper abdomen on (b)(6) 2012. On (b)(6) 2012, the patient received one treatment cycle to the lower abdomen with the coolmax (8. 0) applicator. In addition, on (b)(6) 2012, the patient received two treatment cycles to each flank with the coolcurve (6. 2) applicator. Post treatment phase was uneventful. The treating physician reported that on follow up on (b)(6) 2012, the treated tissue felt like firm normal fat. He did not feel there was any fat necrosis or anything odd to report. On (b)(6) 2012, the physician's office called to report that the treatment area was enlarged and that the physician recommended liposuction to remove the tissue from treated area, making this a reportable event. This case has also been reported for the coolmax applicator in mdr 3007215625-2012-00020 and for the coolcurve applicator in mdr 3007215625-2012-00021.

Manufacturer Narrative

Zeltiq followed up with the physician's office to gather additional information. Per the physician's office, the procedure was conducted successfully with no malfunctions. Zeltiq reviewed the system logs and confirmed that no system malfunction occurred during treatment.

• Brand Name: ZELTIQ COOLCORE (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: 2850648
• MDR Text Key: 3042521
• Report Number: 3007215625-2012-00019
• Device Sequence Number: 1
• Product Code: OOK
• Combination Product (Y/N): N
• Reporter Country Code: US
• 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: 10/24/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/20/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: COOLCORE APP (6.3)
• Device Catalogue Number: BRZ-AP1-063-000
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Date Manufacturer Received: 10/24/2012
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/01/2010
• 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: 11/20/2012 Patient Sequence Number: 1