Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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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As reported to coloplast, though not verified the patient with this device experienced pelvic pain on pelvic sidewall.Mesh erosion and prolene suture erosion in right pelvic sidewall.1st degree cystocele and rectocele.Right side abdominal pain with small mesh exposure in the center of posterior vaginal wall.Excision of exposed vaginal mesh under general anesthesia was performed.Additionally, a yeast infection, mesh visible at the apex of the vagina, friable tissue and bleeding, discomfort and early signs of mesh infection.Exposed mesh at the apex and posterior wall.An operative report was received and documented that mesh resection and cystoscopy under general anesthesia was performed.
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