• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ AESTHETICS INC. ZELTIQ EZ APP 6.3 ZELTIQ VACUUM APPLICATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZELTIQ AESTHETICS INC. ZELTIQ EZ APP 6.3 ZELTIQ VACUUM APPLICATOR Back to Search Results
Model Number EZ APP 6.3
Event Date 08/12/2011
Event Type  Injury  
Event Description

It is alleged that a (b)(6) male patient received two coolsculpting treatments on the lower abdomen with 6. 3 applicator on (b)(6) 2011. Three month post treatment follow up showed increased fat in the treated area. The physician retreated the patient on (b)(6) 2012. On (b)(6) 2012, the physician clarified that the tissue was firm before the second treatment but they were still able to complete the second treatment. Zeltiq made multiple attempts to contact the physician and patient between june and august without success. On (b)(6) 2012, zeltiq personnel visited the clinic and were able to meet with the physician and the patient on his four month follow up visit. The treatment area was still described to be firm. Zeltiq recommended diagnostic treating to which the patient agreed on (b)(6) 2012. On (b)(6) 2012, the patient underwent an ultrasound procedure. The report stated "increase in volume, thickness and density of the described lower abdominal fat not associated with collections or mass. There is no eventration. " on (b)(6) 2012, the patient was seen by a plastic surgeon who recommended liposuction procedure and therefore zeltiq is reporting this event. A follow-up report will be made to the agency if and when new information is received about this case.

 
Manufacturer Narrative

Zeltiq reviewed the system logs for both treatments and confirmed that no system malfunction occurred during both treatments. The clinical group followed up with the physician to collect additional information as it was unclear about the tissue consistency after the first treatment. The case was further complicated by the patient undergoing multiple pressure treatments (lymphatic drainage treatments) after the first coolsculpting treatment.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZELTIQ EZ APP 6.3
Type of DeviceZELTIQ VACUUM APPLICATOR
Manufacturer (Section D)
ZELTIQ AESTHETICS INC.
4698 willow road
pleasanton CA 94588
Manufacturer Contact
gurvinder nanda
4698 willow road
pleasanton , CA 94588
9254742500
MDR Report Key2802334
Report Number3007215625-2012-00014
Device Sequence Number1
Product CodeOOK
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 10/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEZ APP 6.3
Device Catalogue NumberBRZ-AP1-063-000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/12/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2011
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: 10/19/2012 Patient Sequence Number: 1
-
-