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
Unspecified Infection (1930)
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Event Date 08/05/2014 |
Event Type
Injury
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Manufacturer Narrative
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Patient identifier: (b)(6).Study name: (b)(6) study.The complainant indicated that the device remains implanted and 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 on (b)(6) 2017 that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2014, the patient experienced urinary tract infection.She was treated with macrobid and the event resolved on (b)(6) 2014.
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Event Description
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It was reported to boston scientific corporation on august 21, 2017 that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2014, the patient experienced urinary tract infection.She was treated with macrobid and the event resolved on december 15, 2014.Additional information received on july 9, 2018.The event of urinary tract infection experienced by the patient on (b)(6) 2014 resolved on (b)(6) 2014.
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Search Alerts/Recalls
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