FDA Adverse Event Injury Summary report: N

ZELTIQ COOLCORE (6.3)

MDR report key: 2950112 · Received February 6, 2013

Report

Report Number: 3007215625-2013-00014
Event Type: Injury
Date Received: February 6, 2013
Date of Event: September 14, 2012
Report Date: January 9, 2013
Manufacturer: ZELTIQ AESTHETICS INC.
Product Code: OOK
PMA / PMN Number: K120023
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

A MALE PT RECEIVED COOLSCULPTING TREATMENTS ON (B)(6) 2011 WITH THE COOLMIX APPLICATOR (8.0) ON HIS LOWER ABDOMEN AND ON (B)(6) 2011 WITH THE COOLCORE APPLICATOR (6.3) ON HIS UPPER ABDOMEN. THE PT RETURNED TO THE OFFICE ON (B)(6) 2012 AND REPORTED BULGES IN HIS UPPER AND LOWER TREATMENT AREAS. THE PT REPORTED THAT HE NOTICED THE CHANGE APPROXIMATELY 6-8 WEEKS POST-TREATMENT. THE TREATING OFFICE DESCRIBED THE AREA AS FIRM. ON (B)(6) 2012, ZELTIQ WAS INFORMED THAT THE OFFICE HAD CHOSEN TO BEGIN TREATMENT WITH ACCENT RADIO FREQUENCY, WHICH IS GENERALLY USED FOR SKIN TIGHTENING, TO THE ENTIRE ABDOMINAL AREA. THE OFFICE REPORTED ON (B)(6) 2012 THAT THE TREATMENT WAS NOT EFFECTIVE AND THE PT HAD DISCONTINUED THE TREATMENTS. ON (B)(6) 2013, ZELTIQ WAS INFORMED THAT THE PT PLANS TO UNDERGO LASERLIPO, MAKING THIS EVENT REPORTABLE. THIS CASE HAS ALSO BEEN REPORTED FOR COOLMAX APP (8.0) IN MDR 3007215625-2013-00013.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
50293	ZELTIQ COOLCORE (6.3)	ZELTIQ VACUUM APPLICATOR	OOK	ZELTIQ AESTHETICS INC.	COOLCORE APP. 6.3	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	34 YR		Required Intervention