BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068317050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Pain (1994); No Code Available (3191)
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Event Date 11/16/2011 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2011 (implant date) as no event date was reported.This complaint was reported by the patient's lawyer.The device was implanted at (b)(6) hospital, (b)(6) by dr.(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 a pinnacle pelvic floor kit was implanted on (b)(6) 2011.As reported by the patient's attorney, the patient experienced pain, recurrent vesicovaginal fistulas and a painful excision surgery.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Search Alerts/Recalls
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