BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317080 |
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 12/02/2009 |
Event Type
Injury
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-06673 for the associated device.It was reported to boston scientific corporation that an uphold vaginal support system and an advantage fit system were used during a cystoscopy, mid-urethral sling placement, vaginal colpopexy, anterior and posterior repair with mesh insertion procedures performed on (b)(6) 2009 to treat a patient with uterovaginal prolapse and stress urinary incontinence.The patient was taken to the post-anesthesia care unit in stable condition.As reported by the patient's attorney, the patient experienced an unknown injury.
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2009, implant procedure date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).
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Search Alerts/Recalls
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