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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ

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ZELTIQ Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 05/14/2012
Event Type  No Answer Provided  
Event Description

I elected to undergo the zeltiq procedure on my lower and upper abdomen area. The small devices were used in 2 separate sessions. I am now 8 days post procedure and still feel intense burning in my lower abdomen and sharp stabbing pains occasionally. The area is tender to touch. I called the doctor¿s office and was advised that this is unusual and they have done this procedure on many many patients and no one has had this much pain. Date of use: (b)(6) 2012. Reason for use: destroy fat cells.

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Brand NameZELTIQ
Type of DeviceZELTIQ
MDR Report Key2593139
MDR Text Key20915975
Report NumberMW5025554
Device Sequence Number1
Product Code OOK
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/22/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 05/22/2012 Patient Sequence Number: 1