As reported to coloplast though not verified, legal representative stated the patient with this device experienced lower back pain radiating down her hip and leg, urinary incontinence, dysuria, back pain, sepsis, urinary tract infection, myositis in the left thigh, hemodialysis for an acute kidney injury, and a nonoliguric acute kidney injury.Patient had a 5-mm epithelialized hole 1 cm below the urethral meatus in the midline that was infected and displacement of the left side of the device.
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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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