MAUDE Adverse Event Report: ZELTIQ AESTHETICS ZELTIQ COOLMINI APPLICATOR; ZELTIQ VACUUM APPLICATOR

Catalog Number BRZ-AP2-020-000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Discoloration (2074)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

The office reported no errors or device malfunctions during the treatment.Zeltiq reviewed the system logs for the treatment date and confirmed that no system malfunctions occurred during the treatment.

Event Description

On (b)(6) 2016 zeltiq was notified that a female patient had developed blistering and pigment changes post treatment.The patient was treated on (b)(6) 2016 to the submental area using the coolmini applicator.On (b)(6) 2017 zeltiq was informed that the patient had been prescribed triluma topical cream to address pigmentary changes as an intervention measure, making this event reportable.Preexisting medical history of the patient was not able to be obtained by the time of this report.A follow-up report will be made to the agency if and when new information is received about this case.

• Brand Name: ZELTIQ COOLMINI APPLICATOR
• Type of Device: ZELTIQ VACUUM APPLICATOR
• Manufacturer (Section D): ZELTIQ AESTHETICS; 4410 rosewood drive; pleasanton CA 94588
• Manufacturer (Section G): ZELTIQ AESTHETICS; 4410 rosewood drive; pleasanton CA 94588
• Manufacturer Contact: shruti jayakumar ; 4410 rosewood drive; pleasanton, CA 94588 ; 9254742516
• MDR Report Key: 6521086
• MDR Text Key: 73669003
• Report Number: 3007215625-2017-00003
• Device Sequence Number: 1
• Product Code: OOK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162050
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BRZ-AP2-020-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention