On (b)(6) 2018 the patient had 3rd treatment with venus versa system using diamond polar applicator, on her face.The initial diagnosis of the patients that evening was stroke.The final diagnosis is genetic blood disorder.According to md, the incident most likely happened because of her previous medical history.Post investigation, according to the md, the patient did not suffer from stroke and no lateral injuries(as was initially perceived).It was discovered that patient has a genetic blood condition that makes her blood too thick , the incident accordingly most likely happened because of her previous medical history (thrombophlebitis,was prescribed anticoagulant, and later she discontinue anticoagulants; reason for which is unknown).The patient suffered prolong thrombophlebitis in the past and had related surgery on her leg veins 3 months before the treatment.Patient suffered overweight, 75 lb above the average.The patient was initially hospitalized and could not speak, and then her condition improved and she returned home.The clinic knew that the patient used to take anticoagulants medications.Venus versa system treatment parameters: total treatment duration: 30 min: 20 min with the following parameters: rf = 35% = 26.25w; pemf = 100% = 15gauss, rf = 1 mhz, mp = 15 hz, followed by a 10 min treatment with the following parameters: rf = 3 0% = 22.5w; pemf = 100% = 15gauss, rf = 1 mhz, mp = 15 hz.Related system accessory passed service test post event to ensure device appropriate functionality.Several attempts were performed to get further information on patient condition.No reply was received to this date.
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