Date sent to the fda: 04/12/2017.(b)(4).It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2006 and prolift was implanted.It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2006 and tvt-o was implanted.It was reported that the patient underwent mesh revision on (b)(6) 2006.It was reported that the patient underwent anterior repair with urethrolysis with cystoscopy and urethral catheterization on (b)(6) 2007 by dr.(b)(6).It was reported that following the procedure the patient experienced urinary retention, dyspareunia, urgency, urinary hesitation and delay.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
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