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 post operative urinary retention, burning with urination, catheterization, vaginal dryness, dyspareunia, heavy bleeding, abdominal pain, painful ball inside vagina, could feel a scab, gush of fluid, cramping, urinary tract infections, device erosion, pelvic and perineal pain, intermittent vaginal bleeding, hematuria, dysuria, urinary urgency, urge incontinence, urinary frequency, inadequate pelvic muscles, nocturia, atrophic vaginitis, chronic constipation, incomplete bladder emptying, post operative pain, urine analysis with trace blood, and a urine analysis color orange with a white blood cell count of 20-40.Patient had explantation of the device, cystoscopy and other procedures under general anesthesia.
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