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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 No Code Available (3191)
Event Date 04/27/2012
Event Type  Injury  
Event Description

It is alleged that a (b)(6) male patient received one coolsculpting treatment with the 8. 0 applicator to lower abdomen. On (b)(6) 2012, the treating physician informed zeltiq that on the 4 month follow up, the patient¿s treated area looked larger and felt doughy. Photos revealed treated area to be irregularly shaped. On (b)(6) 2012, the physician recommended liposuction which was successfully performed on (b)(6) 2012. 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 and confirmed that no system malfunction occurred during treatment. The patient has a history of an umbilical hernia repair prior to having coolsculpting treatment. On (b)(6) 2012, a biopsy from the treatment site was taken. The pathologist concluded that findings suggest fibrosis and scarring possibly related to the patient¿s history of prior surgery with mesh in the area.

 
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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 Key2792329
MDR Text Key3072197
Report Number3007215625-2012-00013
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 09/15/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/12/2012
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 Received09/15/2012
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: 10/12/2012 Patient Sequence Number: 1
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