BOSTON SCIENTIFIC CORPORATION XENFORM; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
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Model Number M0068302470 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/25/2010 |
Event Type
Injury
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital.Implant surgeon for pinnacle and solyx devices: dr.(b)(6).(b)(6) hospital block h6: imdrf patient code e2401 captures the reportable event of unknown injury.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.
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Event Description
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*note: this manufacturer report pertains to the first of three devices used during the same procedure.It was reported to boston scientific corporation that a xenform device was implanted into the patient during a transvaginal hysterectomy + bilateral salpingo - oophorectomy + posterior repair with xenform mesh procedure performed on (b)(6) 2010 for the treatment of uterovaginal prolapse, cystocele rectocele, postmenopausal bleeding and urinary incontinence.Findings showed uterovaginal prolapse with large mid - portion rectocele and central defect.The patient tolerated the procedure well with no complications.As reported by the patient's attorney, the patient experienced an unknown injury.
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Search Alerts/Recalls
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