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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 12/01/2011
Event Type  Injury  
Event Description

It is alleged that a (b)(6) male pt received coolsculpting treatments in (b)(6) 2011 with 8. 0 applicator to his lower abdomen, one cycle; and 6. 3 applicator to his flanks, total two cycles (exact date unk). His abdomen and flanks were treated on the same day. The procedures were performed without any issue. Manual massage was performed immediately after treatment. Two months after the treatment, the pt was satisfied with the outcome. The pt then intensified his physical activities (workout). On 9/11/2012 zeltiq was informed by the physician that the pt had developed enlargement of treatment area with a different texture. The physician stated that the abdominal treatment area is harder than normal to the touch. The physician recommended liposuction which was conducted on 9/27/2012. This case has also been reported for ez app. 6. 3 in mdr 3007215625-2012-00011. A follow-up report will be made to the agency if and when new info is received about this case.

 
Manufacturer Narrative

Per the physician's office, all the procedures were conducted successfully with no malfunctions or error codes. Zeltiq reviewed the system logs for the month of (b)(6) for this physician and confirmed no system malfunction occurred during any treatment.

 
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Brand NameZELTIQ EZ APP 8.0
Type of DeviceZELTIQ VACUUM APPLICATOR
Manufacturer (Section D)
ZELTIQ AESTHETICS, INC
4698 willow rd
pleasanton CA 94588
Manufacturer Contact
gurvinder nanda
4698 willow road
pleasanton, CA 94588
9254742500
MDR Report Key2780602
MDR Text Key3037990
Report Number3007215625-2012-00012
Device Sequence Number1
Product Code OOK
Combination Product (Y/N)N
Reporter Country CodeBR
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 09/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2012
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 Received09/11/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2011
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: 10/05/2012 Patient Sequence Number: 1
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