Additional information was requested and the following was received: the initial approach for the index surgical procedure? - 2016 the patient demographic info: age, weight, bmi at the time of index procedure - na any concurrent procedure/device implantation? - na were there any intra-operative complications? - na when was the mesh exposure first noted by a physician? -(b)(6) 2018 mesh exposure site/location, symptoms and diagnostic confirmation? - right paraurethral sulcus.
Describe medical/surgical intervention for exposure including dates and findings - (b)(6) 2018 trimmed tape in clinic product code and lot # - na what is physician¿s opinion as to the etiology of or contributing factors to this event - na did the patient's condition improve after the device was completely removed? - na.
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