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 Problems
Pain (1994); Scarring (2061)
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Event Date 01/19/2015 |
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 implanted into the patient during a pelvic floor repair procedure including apical suspension and cystocele repair performed on (b)(6) 2014.The procedure was completed without complications.According to the complainant, on (b)(6) 2015, the patient presented with vaginal scarring greater than 1 cm at the vaginal suture line in the anterior compartment.She had associated introital pain and no epithelial separation.The event was reported as mild in severity and the patient was treated with estrogen cream.The event is currently resolving.The investigator assessed the event as pelvic floor related, probably related to the procedure, and probably related to the device.
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Manufacturer Narrative
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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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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported to boston scientific corporation that a xenform tissue repair matrix was implanted into the patient during a pelvic floor repair procedure including apical suspension and cystocele repair performed on (b)(6) 2014.The procedure was completed without complications.According to the complainant, on (b)(6) 2015, the patient presented with vaginal scarring greater than 1 cm at the vaginal suture line in the anterior compartment.She had associated introital pain and no epithelial separation.The event was reported as mild in severity and the patient was treated with estrogen cream.The event is currently resolving.The investigator assessed the event as pelvic floor related, probably related to the procedure, and probably related to the device.Additional information received on july 11, 2018.The event of vaginal scarring presented on (b)(6) 2015 resolved on (b)(6) 2016.
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Search Alerts/Recalls
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