Model Number M0068302470 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Urinary Tract Infection (2120)
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Event Date 01/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).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 repair with xenform procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the subject experienced a lower urinary tract infection.She was treated with levaquin and ciprofloxacin and the event resolved on (b)(6) 2016.
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Manufacturer Narrative
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The patient was also reported under mfr report#3005099803-2016-02201.The event of lower urinary tract infection reported under mfr report#3005099803-2016-00489 and any new event information will be sent under mfr report#3005099803-2016-02201.
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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 repair with xenform procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the subject experienced a lower urinary tract infection.She was treated with levaquin and ciprofloxacin and the event resolved on (b)(6) 2016.
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Search Alerts/Recalls
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