Reported per clinical trial (b)(4): on (b)(6) 2014, the patient underwent multiple recurrent ventral suprapubic open hernia repair procedure during which a xenmatrix surgical graft was trimmed and placed in underlay fashion inter peritoneally, fixated using a suture.Fascia was completely closed using vicryl suture through interrupted stitch.Full skin closure was achieved using sutures.Concomitant procedure includes lysis of adhesion(s).The patient was discharged to home on (b)(6) 2014.On (b)(6) 2014, the patient underwent removal of jackson pratt drain.The patient was discharged on the same day.On (b)(6) 2014, the patient was diagnosed with fistula; the spontaneous draining sinus resolved over time (b)(6) 2015).The ae is clinically assessed to be of mild severity, possibly related to the study device, not related to the procedure and recovered/resolved.The reported adverse event does not meet the definition of an sae (serious adverse event).On (b)(6) 2015, patient underwent physical exam during which ventral suprapubic hernia (3.7 cm2) was diagnosed and confirmed through ct scan on (b)(6) 2015.On (b)(6) 2015 patient underwent an additional surgery and the device was explanted.
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As reported, about three months post implant of xenmatrix, the patient was diagnosed with fistula which resolved with no treatment required.The clinician has assessed the patient¿s postoperative course as "possibly" related to the study device and not related to the procedure.However, based on the information provided, no conclusion can be made.The instructions-for-use supplied with the device lists fistula as a possible complication.Review of manufacturing records confirms product was manufactured to specification.This mdr represent the event of fistula.An additional mdr was submitted to represent the ae of hernia recurrence.Not returned - remains implanted.
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