MAUDE Adverse Event Report: ZELTIQ AESTHETICS,INC. ZELTIQ EZ APP 8.0 ZELTIQ VACUUM APPLICATOR

Model Number EZ APP 8.0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 05/07/2012

Event Type  Injury  

Event Description

It is alleged that a (b)(6) female pt received one coolsculpting treatment cycle with a 8. 0 applicator to upper abdomen on (b)(6) 2012. This was the 4th treatment on this anatomical region, with previous three treatments on (b)(6) 2010. On (b)(6) 2012, three and a half months post treatment the pt complained of "portion of abdomen sticking out. " on (b)(6) 2012, 5 months post treatment, the pt returned and still complained of firm upper abdomen. The treating physician confirmed her observations and recommended several treatment options including one re-treatment with coolsculpting, which the pt declined; wait a while and see if it resolves, and consider surgical removal. On (b)(6) 2012 the pt decided on liposuction to remove the tissue making this a reportable event.

Manufacturer Narrative

Zeltiq followed up with the physician's office to gather additional info. Per the physician's office the procedure was conducted successfully with no malfunctions. Zeltiq reviewed the system logs and confirmed that no sys malfunction occurred during treatment. The pt had several treatment cycles on other body regions including both flanks, lower abdomen and on inner thigh without any issues.

• Brand Name: ZELTIQ EZ APP 8.0
• 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: 2842069
• MDR Text Key: 16533464
• Report Number: 3007215625-2012-00016
• Device Sequence Number: 1
• Product Code: OOK
• Combination Product (Y/N): N
• 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: 10/18/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/12/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: EZ APP 8.0
• Device Catalogue Number: BRZ-AP1-080-000
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 10/18/2012
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/01/2010
• 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: 11/12/2012 Patient Sequence Number: 1