MAUDE Adverse Event Report: ZELTIQ AESTHETICS, INC. ZELTIQ COOLMAX (8.0); ZELTIQ VACUUM APPLICATOR

Model Number COOLMAX APP. 8.0

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Deformity/ Disfigurement (2360)

Event Date 07/01/2012

Event Type  Injury  

Event Description

A male pt in (b)(6) received coolsculpting treatment on (b)(6) 2012 on his mid-abdomen centered on the umbilicus with the coolmax applicator (8.0).During a follow-up visit in (b)(6) 2012, the treating office noticed "tissue stiffening" in the treated area.The pt reported that he noticed the lump 3 months post-treatment.In (b)(6) 2012, the pt underwent a ct scan which indicated that the lump of tissue was fat.Zeltiq received photos on (b)(6) 2012 that showed a centralized abdominal bulge that was greater in size than compared with baseline.On (b)(6) 2013, zeltiq received the ct image and had it independently reviewed by a radiologist who agreed that the lump looked like fat.On (b)(6) 2013, zeltiq was notified that the pt had begun accent ultra treatments to treat the condition, making this case reportable.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.Per the physician's office the procedure was conducted successfully with no malfunctions.Zeltiq reviewed the system logs for the treatment date and confirmed that no system malfunction occurred during treatment.

• Brand Name: ZELTIQ COOLMAX (8.0)
• 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: 2950096
• MDR Text Key: 3156794
• Report Number: 3007215625-2013-00015
• Device Sequence Number: 1
• Product Code: OOK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COOLMAX APP. 8.0
• Device Catalogue Number: BRZ-API-080-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2013
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR