As reported to coloplast, though not verified, the patient with this device experienced pink-tinged urine in urinary catheter tubing, residual mid urethral mobility, vaginal bleeding, bladder spasms, recurrent urinary tract infections (uti), bladder trabeculations with some cystitis noted in bladder, bladder stones, residual mesh erosion through the bladder wall proximal to the trigone described as small threads of mesh, posterior bladder wall exposed mesh approx.1 cm in diameter, cystolithotripsy with holmium laser and removal of exposed mesh with holmium laser and placement of matristem graft in bladder, cystourethroscopy under general anesthesia, suprapubic pain, constipation, urinary analysis positive for leukocytes, a small suture was seen on vaginoscopy.The patient was discharged home with a foley catheter for 4 weeks.She reported bladder irritation and feeling of heaviness cystitis on the anterior bladder wall likely from rubbing against mesh erosion.
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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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