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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ ZELTIQ; COOL SCULPTING SYSTEM
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ZELTIQ ZELTIQ; COOL SCULPTING SYSTEM Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Hyperplasia (1906)
Event Date 08/21/2017
Event Type  Injury  
Event Description
A (b)(6) year old male s/p coolsculpting of the lower abdomen on (b)(6) 2017.This was repeated on (b)(6) 2017 to the lower abdomen.On (b)(6) 2017 patient is noted to have paradoxical fat hyperplasia of the lower abdomen.Patient had coolsculpting of the lower abdomen to reduce localized adiposity.After two seasons, three months apart, patient is noted to have had an increase in localized adiposity without any significant weight change.Caliper pitch measurements went from 50 mm to 65 mm in the treated area.Photos of the patient support this observation.The manufacturer claims the incidence is 1 in 150,000 treatments.I have treated only 54 patients or 84 treatments.My concern is that the incidence of this problem is under reported.It seems quite unlikely that i would or should have ever seen it if the incidence is correct.Dates of use: (b)(6) 2017.
 
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Brand Name
ZELTIQ
Type of Device
COOL SCULPTING SYSTEM
Manufacturer (Section D)
ZELTIQ
4698 willow rd.
pleasanton CA 94588
MDR Report Key6954413
MDR Text Key89671873
Report NumberMW5072775
Device Sequence Number1
Product Code OOK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 10/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2017
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age60 YR
Patient Weight83
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