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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ AESTHETICS INC. ZELTIQ COOLCORE (6.3) ZELTIQ VACUUM APPLICATOR

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ZELTIQ AESTHETICS INC. ZELTIQ COOLCORE (6.3) ZELTIQ VACUUM APPLICATOR Back to Search Results
Model Number COOLCORE APP (6.3)
Device Problem Insufficient Information (3190)
Patient Problem Swelling (2091)
Event Date 04/04/2012
Event Type  Injury  
Event Description

It is alleged that a (b)(6) female patient received two coolsculpting treatment cycles with the coolcore (6. 3) applicator to the upper abdomen on (b)(6) 2012. On (b)(6) 2012, the patient received one treatment cycle to the lower abdomen with the coolmax (8. 0) applicator. In addition, on (b)(6) 2012, the patient received two treatment cycles to each flank with the coolcurve (6. 2) applicator. Post treatment phase was uneventful. The treating physician reported that on follow up on (b)(6) 2012, the treated tissue felt like firm normal fat. He did not feel there was any fat necrosis or anything odd to report. On (b)(6) 2012, the physician's office called to report that the treatment area was enlarged and that the physician recommended liposuction to remove the tissue from treated area, making this a reportable event. This case has also been reported for the coolmax applicator in mdr 3007215625-2012-00020 and for the coolcurve applicator in mdr 3007215625-2012-00021.

 
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 and confirmed that no system malfunction occurred during treatment.

 
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Brand NameZELTIQ COOLCORE (6.3)
Type of DeviceZELTIQ VACUUM APPLICATOR
Manufacturer (Section D)
ZELTIQ AESTHETICS INC.
4698 willow road
pleasanton CA 94588
Manufacturer Contact
gurvinder nanda
4698 willow road
pleasanton, CA 94588
9254742500
MDR Report Key2850648
MDR Text Key3042521
Report Number3007215625-2012-00019
Device Sequence Number1
Product Code OOK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK080521
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 10/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCOOLCORE APP (6.3)
Device Catalogue NumberBRZ-AP1-063-000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received10/24/2012
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: 11/20/2012 Patient Sequence Number: 1
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