Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018, was chosen as a best estimate based on the date of the mesh implant surgery.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a xenform graft materials was implanted into the patient during a paravaginal repair with graft, excision and revision of vaginal mesh (7cm total vaginal mesh wound, modifier 22), posterior repair and perineorrhaphy, cystourethroscopy, excision of labial cyst and use of xenograft procedure performed on (b)(6) 2018 for the treatment of pelvic pain, vaginal mesh exposure, cystocele, urge urinary incontinence, left labial cyst, rectocele and weakened pelvic tissue.As reported by the patient's attorney, the patient has experienced an unspecified injury.
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