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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ ZELTIG COOLSCULPTING

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ZELTIQ ZELTIG COOLSCULPTING Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 10/11/2013
Event Type  Injury  
Event Description

Subject was treated with zeltiq coolsculpting device on (b)(6) 2013. Everything went well during his treatment and at 2 month follow up he was noted to have significant fat loss in the treated area. He completed the study on (b)(6) 2013 with no issues or problems. He contacted me on (b)(6) 2013 to report that he had noted increased fat in the treated love handle area. He was seen at our clinic on (b)(6) 2013 and determined to have increased fat growth (ie increased love handle size) in the treated area compared to his baseline (beginning of the study). He will need to have liposuction to have this extra fat growth removed. The liposuction will be done for cosmetic reasons only as this increased fat growth is not harmful to patient or to his health in any way. This very rare side effect has been seen before in other patients treated with this device and has already been reported to the fda by the manufacturer. We also informed the manufacturer (zeltiq) of this incident.

 
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Brand NameZELTIG COOLSCULPTING
Type of DeviceCOOLSCULPTING
Manufacturer (Section D)
ZELTIQ
pleasanton CA 94588
MDR Report Key3427250
MDR Text Key21045839
Report NumberMW5032367
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 10/18/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/21/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

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