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 UNK166 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Urinary Retention (2119); Urinary Tract Infection (2120)
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Event Date 12/08/2015 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.The complainant indicated that the device was 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 that a xenform soft tissue repair matrix was used during a pelvic floor reconstruction procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2015, the patient experienced difficulty emptying her bladder.A foley catheter was inserted and the problem resolved on (b)(6) 2015.On (b)(6) 2015, the patient also experienced urinary tract infection.She was treated with macrobid and the event is currently resolving.
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Manufacturer Narrative
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(b)(6).
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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 used during a pelvic floor reconstruction procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2015, the patient experienced difficulty emptying her bladder.A foley catheter was inserted and the problem resolved on (b)(6) 2015.On (b)(6) 2015, the patient also experienced urinary tract infection.She was treated with macrobid and the event is currently resolving.Additional information received on january 12, 2016.The event of urinary tract infection was resolved on (b)(6) 2015.
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Search Alerts/Recalls
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