Model Number M0068302450 |
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 12/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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The complete patient id is (b)(6).The complainant indicated that the device is 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 tissue repair matrix was used during a pelvic floor reconstruction with xenform including vaginal approach hysteropexy and cystocele repair procedure performed on (b)(6) 2016.According to the complainant, on (b)(6) 2016, the patient experienced urinary retention.No treatment was given and the event is currently resolving.
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Manufacturer Narrative
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Outcomes attributed to adverse event: updated.
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Event Description
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It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor reconstruction with xenform including vaginal approach hysteropexy and cystocele repair procedure performed on (b)(6) 2016.According to the complainant, on (b)(6) 2016, the patient experienced urinary retention.No treatment was given and the event is currently resolving.Additional information received on august 21, 2018: the difficulty emptying bladder experienced on (b)(6) 2016 was treated with catheterization and resolved on (b)(6) 2017.
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Search Alerts/Recalls
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