(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: consultant at the hospital put as much info available at the time of notification: the patient demographic info: age, gender, weight, bmi at the time of index procedure? date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? the initial approach for the index surgical procedure? were any concomitant procedures performed? what were current symptoms following the index surgical procedure? onset date? was medical intervention provided for the urinary tract infections? results? when was the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? describe medical/surgical intervention for exposure including dates? -what were the findings on reoperation? -are there any pictures available for evaluation? product code and lot number? other relevant patient history/concomitant medications? 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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