BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068505000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Date 11/19/2012 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2012, implant date, as no event date was reported.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an obtryx system - halo was implanted into the patient during vaginal hysterectomy, anterior and posterior vaginal compartment, sacrospinous colpopexy and sling procedure performed on (b)(6) 2012 to treat uterovaginal prolapse, endometriosis of uterus and stress incontinence.As reported by the patient's attorney, after the implantation, the patient had experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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Search Alerts/Recalls
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