(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: the surgeon has informed that she doesn¿t have the additional information, as she¿s only seen the patient for management of defective tvt.No further information available.The patient demographic info: age, weight, bmi at the time of index procedure? indication and name of initial surgical procedure in 2006? were there any intra-operative complications? other relevant patient comorbidities? any concurrent procedure/device implantation? date and results of laparoscopy and cystoscopy? was the mesh erosion into the vagina diagnosed and when? what medical intervention was given for the pain management? results? please specify details of any medical /surgical interventions for mesh erosion if diagnosed? product code and lot number? what is physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient's current status?.
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