It is alleged that a (b)(6) female pt received one coolsculpting treatment cycle with a 8.
0 applicator to upper abdomen on (b)(6) 2012.
This was the 4th treatment on this anatomical region, with previous three treatments on (b)(6) 2010.
On (b)(6) 2012, three and a half months post treatment the pt complained of "portion of abdomen sticking out.
" on (b)(6) 2012, 5 months post treatment, the pt returned and still complained of firm upper abdomen.
The treating physician confirmed her observations and recommended several treatment options including one re-treatment with coolsculpting, which the pt declined; wait a while and see if it resolves, and consider surgical removal.
On (b)(6) 2012 the pt decided on liposuction to remove the tissue making this a reportable event.
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