[5111965]
(b)(4) 2014: this is cutera's response report to mdr report (mw5035588) submitted to the fda medwatch program on (b)(4) 2014 by the device owner/operator and received at cutera (b)(4) 2014. The patient had a trusculpt treatment to the abdomen and posterior thighs on (b)(6) 2013. The patient returned for her second trusculpt treatment on (b)(6) 2014. The device owner/operator contacted cutera (b)(6) 2014 with clinical complaint of "generalized swelling" and weight gain of "8 lbs. ", tenderness in the treatment area and "nodules" that resolved. The device owner/operator sent 3 photos that are dated (b)(6) 2014. There is no evidence of patient injury or impairment in the photos. The patient's weight was not documented in the patient medical record before or after the trusculpt treatments and at the time the patient complained of "weight gain". The patient has not been evaluated by a physician. "swelling, bruising, nodules and pain" are known short term side effects of the procedure and are listed in the device labeling. "weight gain" is not a known side effect associated with the procedure. The device owner/operator has contacted cutera on numerous occasions to report clinical complaints of "patient injury" and has demanded a refund for the equipment purchased in order to buy a different technology. During each contact with the device owner/operator cutera has requested all supporting medical or scientific information that reasonably suggests that a cutera device may have caused or contributed to a serious patient injury/impairment. Cutera has repeatedly requested copies of physician evaluations and documentation of the patient medical care and have not been provided with any medical documents that confirm the patient has received professional medical intervention for a serious patient injury or impairment. There are no service complaints associated with the device and the device has not been returned to cutera.
Patient Sequence No: 1, Text Type: D, B5