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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ AESTHETICS INC. ZELTIQ COLLMAX (8.0) ZELTIQ VACUUM APLICATOR

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ZELTIQ AESTHETICS INC. ZELTIQ COLLMAX (8.0) ZELTIQ VACUUM APLICATOR Back to Search Results
Model Number COOLMAX APP. 8.0
Event Date 11/01/2011
Event Type  Injury  
Event Description

A male pt informed zeltiq that he rec'd coolsculpting treatment in (b)(6) 2011 with the coolmax app (8. 0) on his lower abdomen. In (b)(6) 2011, the pt noticed the area was larger. By (b)(6) 2012, the enlargement was still present. The pt reported that the bulge was firmer than the surrounding area. In (b)(6) 2012, the pt had a second treatment to the same area. The bulge initially decreased but increased again 6-8 weeks after the second treatment. The pt described the area as firmer than surrounding tissues. The pt visited a plastic surgeon on (b)(6) 2012 who recommended possible treatment options including ultrasound treatments, vibratory treatments, or liposuction. The pt chose to try vibratory treatments with an otc personal massager. On (b)(6) 2012, the pt visited another physician who recommended the pt stop massaging the area but instead try 60% dmso and medical ultrasound once a week. On (b)(6) 2013, the pt was examined by the treating physician who determined that the pt's condition will not resolve on its own and will need surgical intervention, making this case reportable.

 
Manufacturer Narrative

For this case, zeltiq was contacted by the pt who wished to remain anonymous. As such, zeltiq was unable to obtain system logs and applicator serial number from the physician's office. The pt reported that the treatments were uneventful. A follow-up report will be made to the agency if and when new info is rec'd about this case.

 
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Brand NameZELTIQ COLLMAX (8.0)
Type of DeviceZELTIQ VACUUM APLICATOR
Manufacturer (Section D)
ZELTIQ AESTHETICS INC.
4698 willow road
pleasanton CA 94588
Manufacturer Contact
shruti jayakumar
4698 willow road
pleasanton , CA 94588
8254742500
MDR Report Key3023853
Report Number3007215625-2013-00019
Device Sequence Number1
Product CodeOOK
Report Source Manufacturer
Source Type User facility
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCOOLMAX APP. 8.0
Device Catalogue NumberBRZ-API-080-000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/27/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/26/2013 Patient Sequence Number: 1
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