It is alleged that a (b)(6) female patient received two coolsculpting treatment cycles with the coolcore (6.
3) applicator to the upper abdomen on (b)(6) 2012.
On (b)(6) 2012, the patient received one treatment cycle to the lower abdomen with the coolmax (8.
0) applicator.
In addition, on (b)(6) 2012, the patient received two treatment cycles to each flank with the coolcurve (6.
2) applicator.
Post treatment phase was uneventful.
The treating physician reported that on follow up on (b)(6) 2012, the treated tissue felt like firm normal fat.
He did not feel there was any fat necrosis or anything odd to report.
On (b)(6) 2012, the physician's office called to report that the treatment area was enlarged and that the physician recommended liposuction to remove the tissue from treated area, making this a reportable event.
This case has also been reported for the coolmax applicator in mdr 3007215625-2012-00020 and for the coolcurve applicator in mdr 3007215625-2012-00021.
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