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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ AESTHETICS, INC. ZELTIQ EZ APP 8.0 ZELTIQ VACUUM APPLICATOR

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ZELTIQ AESTHETICS, INC. ZELTIQ EZ APP 8.0 ZELTIQ VACUUM APPLICATOR Back to Search Results
Model Number EZ APP 8.0
Device Problem Insufficient Information (3190)
Patient Problem Inflammation (1932)
Event Date 07/16/2012
Event Type  Injury  
Event Description

It is alleged that a (b)(6) male pt received coolsculpting treatment on (b)(6) 2011, procedure was conducted successfully. Treating physician's office did not recall any malfunctions or error codes. On (b)(6) 2011, the office contacted zeltiq to report that during follow up on (b)(6) 2011, the pt claimed that the fatty tissue in the treatment area had increased. The physician saw the pt on that day and reported that the condition was inflammation that may resolve over time and asked the pt to be seen in 3 months. However, on 03/07/2012 zeltiq received information from the physician who reported that although the pt condition's has not changed, he has scheduled the pt for surgery on (b)(6) 2012. Treating physician was unable to establish causal relationship between the treatment and the pt's condition. It is zeltiq's policy to be conservative and to make this report.

 
Manufacturer Narrative

A follow-up report will be made to the agency if and when new information is received about this case.

 
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Brand NameZELTIQ EZ APP 8.0
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 Key2534481
MDR Text Key18042112
Report Number3007215625-2012-00003
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 12/21/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEZ APP 8.0
Device Catalogue NumberBRZ-AP1-080-000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received12/21/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2011
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: 04/10/2012 Patient Sequence Number: 1
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