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 constipation, abdominal distension, no urge to void and unable to feel when urinating, urinary retention, progressive urinary retention, pain, urinary urgency, nocturia, urinary difficulty, urinary frequency, unable to feel urge to defecate in lower abdomen, urinary tract infections, urinary dyssynergia, chronic fatigue, pelvic floor dysfunction, and dysuria.Patient had revision of the device with transection and cystoscopy under general anesthesia.
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