It was reported to boston scientific corporation that an upsylon y-mesh kit was implanted during a laparoscopic, sacrocolpopexy, posterior repair and cystoscopy procedure performed on (b)(6) 2016, for the treatment of prolapse.As reported by the patient's attorney, the patient had experienced an unspecified injury.
|
Date of event: date of event was approximated to (b)(6) 2016, the date the sling was implanted, as no event date was reported.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
|