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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ COOL SCULPTING WITH CAVITAITON
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ZELTIQ COOL SCULPTING WITH CAVITAITON Back to Search Results
Device Problems Inadequate Instructions for Healthcare Professional (1319); Improper or Incorrect Procedure or Method (2017)
Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Event Date 11/03/2017
Event Type  Injury  
Event Description
Reporter stated that she is a spa manager and about 1 month ago a client named (b)(6) was injured by (b)(6) when receiving a cool sculpting treatment.The device came from (b)(6).Reporter unaware that it was not fda approved.No paperwork or training came with the device.It was brought in from europe and training given over (b)(6).During the process the temperature is low so that the abdomen is like frozen.(b)(6) had the handle settings over the navel incorrect and (b)(6) received a burn.She had to go to the (b)(6) center because there were blisters and the skin was completely black similar to frostbite.(b)(6) has filed a lawsuit and the only reason i know is because i answered the phone when the attorney called the spa.(b)(6) is the owner and i told him that (b)(6) was not comfortable giving the treatments.He said the only way for her to get comfortable is with practice.She should not be allowed to practice on people without the proper training.The name of the facility is (b)(6).
 
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Brand Name
COOL SCULPTING WITH CAVITAITON
Type of Device
COOL SCULPTING
Manufacturer (Section D)
ZELTIQ
MDR Report Key7086662
MDR Text Key94198443
Report NumberMW5073752
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 Other
Type of Report Initial
Report Date 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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