As reported to coloplast, though not verified, legal representative stated the patient with this device experienced recurrent urinary tract infection, left pyelonephritis, dysuria, flank pain, positive urinalysis, urine culture with <10,000 cfu/ml gram negative bacilli two colony types, acute vaginitis, gross hematuria and a urine culture with 20,000 cfu/ml escherichia coli.The patient had a diagnostic cystoscopy with bladder biopsy and colposcopy under general anesthesia for recurrent urinary tract infections.Bladder biopsies indicate chronic cystitis with focal squamous metaplasia.
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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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