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
Insufficient Information (4580)
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Event Date 10/15/2007 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2007, implant date, as no event date was reported.(b)(6).(b)(4).
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Event Description
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It was reported to boston scientific corporation that an obtryx halo single system device was implanted during an anterior and posterior colporrhaphy utilizing the non bsc plus mesh systems, mid-urethral sling and cystoscopy procedures performed on (b)(6) 2007 for the treatment of pelvic organ prolapse and stress urinary incontinence.The patient tolerated the procedure well and went to the recovery room in stable condition.As reported by the patient's attorney, the patient experienced an unspecified injury.
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