BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
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 08/25/2014 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2014, implant 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).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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This manufacturer report pertains to one of two devices implanted during the same procedure and in the same patient.It was reported to boston scientific corporation that an uphold (tm) lite with capio slim was used during an anterior and posterior vaginal repair, cystoscopy, advantage boston sling and uphold mesh insertion procedure performed on (b)(6) 2014 to treat vaginal prolapse.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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