It was reported that during a myosure procedure for uterine tissue removal, the fluid deficit rose quickly to 2500ml.The patient exhibited "fluid overload and pulmonary edema".The physician administered "20ml of lasix".The procedure was completed, but the patient "[was] found with a low blood oxygen level." the patient was under observation to monitor blood oxygen level.On (b)(6) 2014, it was reported that after the procedure, the "patient was observed and discharged.[the] physician has shared that she is doing well without further complication.".
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Lot number of the disposable device not provided by the complainant, therefore, the expiration date is not known.The disposable device is not being returned; therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was not able to be conducted for the myosure system as the lot number was not provided by the complainant.(b)(4).
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