MAUDE Adverse Event Report: ZELTIQ AESTHETICS INC. ZELTIQ COLLMAX (8.0); ZELTIQ VACUUM APLICATOR

Model Number COOLMAX APP. 8.0

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 11/01/2011

Event Type  Injury  

Event Description

A male pt informed zeltiq that he rec'd coolsculpting treatment in (b)(6) 2011 with the coolmax app (8.0) on his lower abdomen.In (b)(6) 2011, the pt noticed the area was larger.By (b)(6) 2012, the enlargement was still present.The pt reported that the bulge was firmer than the surrounding area.In (b)(6) 2012, the pt had a second treatment to the same area.The bulge initially decreased but increased again 6-8 weeks after the second treatment.The pt described the area as firmer than surrounding tissues.The pt visited a plastic surgeon on (b)(6) 2012 who recommended possible treatment options including ultrasound treatments, vibratory treatments, or liposuction.The pt chose to try vibratory treatments with an otc personal massager.On (b)(6) 2012, the pt visited another physician who recommended the pt stop massaging the area but instead try 60% dmso and medical ultrasound once a week.On (b)(6) 2013, the pt was examined by the treating physician who determined that the pt's condition will not resolve on its own and will need surgical intervention, making this case reportable.

Manufacturer Narrative

For this case, zeltiq was contacted by the pt who wished to remain anonymous.As such, zeltiq was unable to obtain system logs and applicator serial number from the physician's office.The pt reported that the treatments were uneventful.A follow-up report will be made to the agency if and when new info is rec'd about this case.

• Brand Name: ZELTIQ COLLMAX (8.0)
• Type of Device: ZELTIQ VACUUM APLICATOR
• Manufacturer (Section D): ZELTIQ AESTHETICS INC.; 4698 willow road; pleasanton CA 94588
• Manufacturer Contact: shruti jayakumar ; 4698 willow road; pleasanton, CA 94588 ; 8254742500
• MDR Report Key: 3023853
• MDR Text Key: 3320598
• Report Number: 3007215625-2013-00019
• Device Sequence Number: 1
• Product Code: OOK
• Combination Product (y/n): N
• PMA/PMN Number: K120023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2013
• 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?: No
• Date Manufacturer Received: 02/27/2013
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR