BOSTON SCIENTIFIC CORPORATION XENFORM; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Scar Tissue (2060); Urinary Retention (2119); Prolapse (2475); No Code Available (3191)
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Event Date 06/24/2010 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device is implanted and 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 graft material device was implanted into the patient during a procedure performed on (b)(6) 2006.As reported by the patient's attorney, the patient underwent implantation of a non - boston scientific device, cystoscopy and examination on (b)(6) 2010 due to stress urinary incontinence, cystocele, vaginal scarring and urinary retention.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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