FDA Adverse Event Injury Summary report: N

ZELTIQ EZ APP 8.0

MDR report key: 2842069 · Received November 12, 2012

Report

Report Number: 3007215625-2012-00016
Event Type: Injury
Date Received: November 12, 2012
Date of Event: May 7, 2012
Report Date: October 18, 2012
Manufacturer: ZELTIQ AESTHETICS,INC.
Product Code: OOK
PMA / PMN Number: K080521
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ZELTIQ FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADDITIONAL INFO. PER THE PHYSICIAN'S OFFICE THE PROCEDURE WAS CONDUCTED SUCCESSFULLY WITH NO MALFUNCTIONS. ZELTIQ REVIEWED THE SYSTEM LOGS AND CONFIRMED THAT NO SYS MALFUNCTION OCCURRED DURING TREATMENT. THE PT HAD SEVERAL TREATMENT CYCLES ON OTHER BODY REGIONS INCLUDING BOTH FLANKS, LOWER ABDOMEN AND ON INNER THIGH WITHOUT ANY ISSUES.

Description of Event or Problem · 1

IT IS ALLEGED THAT A (B)(6) FEMALE PT RECEIVED ONE COOLSCULPTING TREATMENT CYCLE WITH A 8.0 APPLICATOR TO UPPER ABDOMEN ON (B)(6) 2012. THIS WAS THE 4TH TREATMENT ON THIS ANATOMICAL REGION, WITH PREVIOUS THREE TREATMENTS ON (B)(6) 2010. ON (B)(6) 2012, THREE AND A HALF MONTHS POST TREATMENT THE PT COMPLAINED OF "PORTION OF ABDOMEN STICKING OUT." ON (B)(6) 2012, 5 MONTHS POST TREATMENT, THE PT RETURNED AND STILL COMPLAINED OF FIRM UPPER ABDOMEN. THE TREATING PHYSICIAN CONFIRMED HER OBSERVATIONS AND RECOMMENDED SEVERAL TREATMENT OPTIONS INCLUDING ONE RE-TREATMENT WITH COOLSCULPTING, WHICH THE PT DECLINED; WAIT A WHILE AND SEE IF IT RESOLVES, AND CONSIDER SURGICAL REMOVAL. ON (B)(6) 2012 THE PT DECIDED ON LIPOSUCTION TO REMOVE THE TISSUE MAKING THIS A REPORTABLE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZELTIQ EZ APP 8.0	ZELTIQ VACUUM APPLICATOR	OOK	ZELTIQ AESTHETICS,INC.	EZ APP 8.0	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Required Intervention