Model Number M0068302470 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); No Consequences Or Impact To Patient (2199)
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Event Date 08/24/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).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 that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2017, the patient experienced dyspareunia.She was treated with physical therapy and the event has not yet resolved.
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Manufacturer Narrative
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Correction to: race.Patient identifier: (b)(6).Report source: study name: (b)(6).(b)(4).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 that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2017, the patient experienced dyspareunia.She was treated with physical therapy and the event has not yet resolved.Additional information received on july 28, 2020.The event of dyspareunia was present at the patient's baseline and has not worsened in frequency or severity.
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Search Alerts/Recalls
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