As reported to coloplast, though not verified, legal representative stated the patient with this device experienced postop bleeding, mild dark orange mucous-like discharge, device extrusion on right lateral wall of vagina, a cystoscopy with about 1.5 cm of device exposure on the right side, and a urinary problem.Patient had a transvaginal resection of exposed device under general anesthesia.Pathology noted a synthetic material consistent with device and soft tissue showing reactive changes.
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Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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