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
Injury (2348)
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Event Date 07/18/2012 |
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.(b)(6).(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 uphold vaginal support system was implanted into the patient during a vaginal hysterectomy + vaginal repair with mesh + cystoscopy procedure performed on (b)(6) 2012.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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Search Alerts/Recalls
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