BOSTON SCIENTIFIC - MARLBOROUGH XENFORM SOFT TISSUE REPAIR MATRIX; 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 Problem
Urinary Retention (2119)
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Event Date 04/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device will not 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 soft tissue repair matrix was implanted on (b)(6) 2015 during a pelvic floor reconstruction procedure.According to the complainant, on (b)(6) 2016, the patient had difficulty emptying her bladder.No treatment was given and the event has not yet resolved.
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Search Alerts/Recalls
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