(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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure? product code and lot number implanted during initial procedure, sacrocolpopexy in 2005? will product be returned, return date and tracking information? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? the initial approach for the index surgical procedure ? any concurrent procedure/device implantation? were there any intra-operative complications? what were current symptoms following the index surgical procedure, sacrocolpopexy in 2005? onset date? what was a reason/indication for partial removal and bowel resection on (b)(6) 2018? when was the mesh erosion/exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? date - time of onset of infection from the initial surgical procedure in 2005? were cultures performed? results? what medical intervention was performed? results? what is physician¿s opinion as to the etiology of or contributing factors to the event on (b)(6) 2018? what is the patient's current status?.
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