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.
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