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
Folded (2630)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 in (b)(6) 2014.According to the complainant, on an unknown date after the procedure, the patient noticed a vein on her vaginal wall during intercourse.Upon further examination, the physician found that the xenform had folded over near the rectum.The physician took out the folded part of the xenform during a cystocele repair procedure performed on (b)(6) 2014.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Device was reported as implanted on an unknown date in (b)(6) 2014.Reported event xenform graft folded.The complainant indicated that the device will not be returned for investigation.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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