As reported to coloplast, though not verified, legal representative stated the patient with this device experienced device erosion.Patient had examination under anesthesia, partial explantation of device, suture closure of vaginal defect or dead space and a cystoscopy.Intraoperative findings noted full thickness erosion of device from one periurethral sulcus to the other at about 4 cm in length, the right sided distal portion noted to be well incorporated into the tissue and was excised to the level of the inferior pubic ramus bilaterally with about 2.5 cm removed from the right side.
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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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