MAUDE Adverse Event Report: ZELTIQ AESTHETICS INC. ZELTIQ APPLICATOR ZELTIQ VACUUM APPLICATOR

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 05/01/2010

Event Type  Injury  

Event Description

It is alleged that a male patient in the (b)(6) received coolsculpting treatment in (b)(6) 2010 on his left flank. Two months after the treatment, there was reportedly a slight enlargement of the treatment area. In (b)(6) 2012, the left flank was reportedly increased in size. On (b)(6) 2012, the patient's weight was recorded at (b)(6) increase from a baseline of (b)(6). On (b)(6) 2012, the patient underwent an ultrasound which indicated a possible lipoma. On (b)(6) 2012, zeltiq was notified that the patient will be undergoing a liposuction procedure to correct the condition, making this a reportable event. A follow-up report will be made to the agency if and when new information is received about this case.

Manufacturer Narrative

Zeltiq followed up with the physician's office to gather additional information but was unable to obtain the serial number and logs for the applicator used. No device malfunction was reported to zeltiq.

• Brand Name: ZELTIQ APPLICATOR
• Type of Device: ZELTIQ VACUUM APPLICATOR
• Manufacturer (Section D): ZELTIQ AESTHETICS INC.; 4698 willow road; pleasanton CA 94588
• Manufacturer Contact: shruti jayakumar ; 4698 willow road; pleasanton, CA 94588 ; 9254742500
• MDR Report Key: 2878976
• MDR Text Key: 2904389
• Report Number: 3007215625-2012-00029
• Device Sequence Number: 1
• Product Code: OOK
• Combination Product (Y/N): N
• Reporter Country Code: RP
• PMA/PMN Number: K080521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/18/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/17/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Date Manufacturer Received: 11/18/2012
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• 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: 12/17/2012 Patient Sequence Number: 1