BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502110 |
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 02/23/2012 |
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.This event was reported by the patient's legal representation.The implant surgeon is: dr.(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 advantage fit system was implanted into the patient during laparoscopic right cystectomy, anterior & posterior vaginal and advantage sling with cystoscopy procedures performed on (b)(6) 2012 to treat right ovarian cyst, anterior & posterior vaginal prolapse and stress incontinence.As reported by the patient's attorney, after the implantation, the patient experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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