BOSTON SCIENTIFIC CORPORATION XENFORM; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
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Model Number M0068302470 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); No Code Available (3191)
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Event Date 01/06/2010 |
Event Type
Injury
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Manufacturer Narrative
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(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 xenform device was implanted on (b)(6) 2007 for repair of rectovaginal fistula.As reported by the patient's attorney, the patient underwent additional procedures for fistula repair on (b)(6) 2010, (b)(6) 2010, (b)(6) 2010 and (b)(6) 2010 due to persistent rectovaginal fistula.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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