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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ AESTHETICS, INC. ZELTIQ COOLMAX (8.0) ZELTIQ VACUUM APPLICATOR

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ZELTIQ AESTHETICS, INC. ZELTIQ COOLMAX (8.0) ZELTIQ VACUUM APPLICATOR Back to Search Results
Model Number COOLMAX APP. 8.0
Event Date 07/01/2012
Event Type  Injury  
Event Description

A male pt in (b)(6) received coolsculpting treatment on (b)(6) 2012 on his mid-abdomen centered on the umbilicus with the coolmax applicator (8. 0). During a follow-up visit in (b)(6) 2012, the treating office noticed "tissue stiffening" in the treated area. The pt reported that he noticed the lump 3 months post-treatment. In (b)(6) 2012, the pt underwent a ct scan which indicated that the lump of tissue was fat. Zeltiq received photos on (b)(6) 2012 that showed a centralized abdominal bulge that was greater in size than compared with baseline. On (b)(6) 2013, zeltiq received the ct image and had it independently reviewed by a radiologist who agreed that the lump looked like fat. On (b)(6) 2013, zeltiq was notified that the pt had begun accent ultra treatments to treat the condition, making this case reportable. 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. 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.

 
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Brand NameZELTIQ COOLMAX (8.0)
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 Key2950096
Report Number3007215625-2013-00015
Device Sequence Number1
Product CodeOOK
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 01/17/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCOOLMAX APP. 8.0
Device Catalogue NumberBRZ-API-080-000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/17/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2010
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: 02/06/2013 Patient Sequence Number: 1
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