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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ AESTHETICS INC. ZELTIQ APPLICATOR ZELTIQ VACUUM APPLICATOR
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ZELTIQ AESTHETICS INC. ZELTIQ APPLICATOR ZELTIQ VACUUM APPLICATOR Back to Search Results
Event Date 05/01/2010
Event Type  Injury  
Event Description

It is alleged that a male patient in the (b)(6) received coolsculpting treatment in (b)(6) 2010 on his left flank. Two months after the treatment, there was reportedly a slight enlargement of the treatment area. In (b)(6) 2012, the left flank was reportedly increased in size. On (b)(6) 2012, the patient's weight was recorded at (b)(6) increase from a baseline of (b)(6). On (b)(6) 2012, the patient underwent an ultrasound which indicated a possible lipoma. On (b)(6) 2012, zeltiq was notified that the patient will be undergoing a liposuction procedure to correct the condition, making this a reportable event. 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 but was unable to obtain the serial number and logs for the applicator used. No device malfunction was reported to zeltiq.

 
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Brand NameZELTIQ APPLICATOR
Type of DeviceZELTIQ 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 Key2878976
Report Number3007215625-2012-00029
Device Sequence Number1
Product CodeOOK
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 11/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received11/18/2012
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 Unkown

Patient TREATMENT DATA
Date Received: 12/17/2012 Patient Sequence Number: 1
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