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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As reported to coloplast, though not verified, legal representative stated the patient with this device experienced urinary tract infection with >100,000 cfu/ml extended spectrum beta lactamase e.Coli that was treated with macrodantin, device erosion, and vaginal discharge.The device was explanted under general anesthesia.Findings noted the device was completely eroded with epithelium growing underneath the device.On the right side, upon tugging on the device the device became completely detached from the obturator internus muscle together with the prolene suture.
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