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 device erosion, stress urinary incontinence, urinary tract infection, urinary symptoms attributed with intercourse, urine culture positive for e.Coli.A physical exam noted vaginal atrophy with a 1 cm area of device erosion directly under the urethra.Patient had the device explanted and cystoscopy.Interoperative findings noted mild urethral meatus prolapse, significant periurethral ulceration circumferentially around the urethra 1 cm exposed vaginal device, approximately 1 cm inferior to the urethral opening, and extreme vaginal atrophy.
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