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
Insufficient Information (4580)
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Event Date 10/12/2009 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to implant date of (b)(6) 2009, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).
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Event Description
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It was reported to boston scientific corporation that a solyx sis system was used during a laparotomy, cystoscopy and tension-free vaginal tape procedures performed on (b)(6) 2009 to treat a female patient with stress urinary incontinence.There were no complications during the implant procedure and the patient was taken to the recovery room in good condition.As reported by the patient's attorney, the patient experienced an unknown injury.
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