BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068504001 |
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 07/28/2015 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2015, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: dr.(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 was implanted into the patient during vaginal hysterectomy and sling placement procedures performed on (b)(6) 2015 to treat menorrhagia.As reported by the patient's attorney, after the implantation, the patient suffered from 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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