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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swelling (2091)
Event Date 05/07/2012
Event Type  Injury  
Event Description

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.

 
Manufacturer Narrative

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.

 
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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 Key2842069
MDR Text Key16533464
Report Number3007215625-2012-00016
Device Sequence Number1
Product Code OOK
Combination Product (Y/N)N
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 10/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2012
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? Yes
Date Manufacturer Received10/18/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2010
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: 11/12/2012 Patient Sequence Number: 1
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