[5233026]
This report is the manufacturer's response to mdr report (mw5035600) submitted to the fda medwatch program on (b)(6) 2014 by the device owner/operator. The date of the event is (b)(6) 2013. The alleged side effects were reported by the device user facility to cutera (device manufacturer) during separate phone conversations and email exchanges dated from (b)(6) 2013 and (b)(6) 2014. The device user facility reported that the patient experienced a wide range of physical symptoms such as "weight gain", "bloating", "water retention", "texture changes", "lymphatic damage", "full blown menopause", etc. 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 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. The device owner/operator did provide 5 out of focus photos that are dated (b)(6) 2014. The photos are unremarkable in presentation and do not demonstrate a serious patient injury or impairment. The patient was also receiving other aesthetic treatments in the same area as the trusculpt treatment. The device owner/operator reported the patient was also receiving "velashape" treatments (used for reduction in cellulite) and "lymphatic drainage massage". The device user facility did not report that the device failed or was defective. The handpieces used to perform the treatments were returned to the manufacturer as a routine return, non-complaint, "treatment refill" after all the allotted treatments on the handpiece were consumed by the user facility. The device console was evaluated on 2 separate occasions ((b)(6) 2013) for service complaints and a system upgrade. The device evaluations were routine and not related to a clinical complaint or patient injury. After careful review of the device history, the fda maude database and the inability of the device user facility to provide any objective evidence to support the claim of patient injury, the device manufacturer has determined that this clinical complaint is not reportable to the fda. The device manufacturer is not aware of any medical or scientific information that reasonably suggests that an mdr reportable event has occurred with the manufacturer's device.
Patient Sequence No: 1, Text Type: D, B5