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
Urinary Retention (2119)
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Event Date 02/01/2016 |
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 tissue repair matrix was used during a pelvic floor repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced difficulty emptying her bladder.There was no treatment administered.
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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 repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced difficulty emptying her bladder.There was no treatment administered.Additional information received april 6, 2017.On (b)(6) 2017, the subject experienced a urinary tract infection.She was treated with macrobid and the event has not yet resolved.The investigator assessed the event as mild in severity, pelvic floor related, possibly related to the procedure, and possibly related to the device.
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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 repair procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced difficulty emptying her bladder.There was no treatment administered.Additional information received april 6, 2017.On (b)(6) 2017, the subject experienced a urinary tract infection.She was treated with macrobid and the event has not yet resolved.The investigator assessed the event as mild in severity, pelvic floor related, possibly related to the procedure, and possibly related to the device.Additional information received on february 8, 2018.The event of urinary tract infection on (b)(6) 2017 was resolved on (b)(6) 2017.
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Search Alerts/Recalls
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