BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507000 |
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 03/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: date of event was approximated to 03/07/2017 (implant date) as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 a solyx sis system was implanted on (b)(6) 2017.As reported by the patient's attorney, the patient 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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