(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure? date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? the initial approach for the index surgical procedure? were there any intra-operative complications? any concurrent procedure/device implantation? when was the mesh extrusion first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? are there any medical/surgical intervention for mesh extrusion planning or performed?if yes, please provide dates and surgical findings/results? when was the urinary frequency/over active bladder started? was any medical intervention done for over active bladder? results? other relevant patient history/concomitant medications? product code and lot #? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
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