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
Vaginal Mucosa Damage (2124)
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Event Date 04/20/2015 |
Event Type
Injury
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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) 2014.The procedure was completed without complications.According to the complainant, on (b)(6) 2015, the patient presented with a suture exposure in the vagina of less than one centimeter away from the area of the suture line.The suture was excised and the event was reported to be resolving.
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Manufacturer Narrative
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The complainant indicated that the device 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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Manufacturer Narrative
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(b)(4).
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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) 2014.The procedure was completed without complications.According to the complainant, on (b)(6) 2015, the patient presented with a suture exposure in the vagina of less than one centimeter away from the area of the suture line.The suture was excised and the event was reported to be resolving.Additional information received on october 1, 2015 - on (b)(6) 2015, the patient experienced difficulty emptying her bladder.No treatment was given and the event has not yet resolved.
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Search Alerts/Recalls
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