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 12/11/2009 |
Event Type
Injury
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Event Description
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*note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during a cystocele repair with mesh + vaginal vault suspension with mesh + transvaginal tape procedure performed on (b)(6) 2009 to treat pelvic organ prolapse and stress urinary incontinence.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 date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) health system.(b)(6).Adverse event problem: imdrf patient code e2401 captures the reportable event of unspecified injury.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.
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Search Alerts/Recalls
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