As reported to coloplast, though not verified, legal representative stated the patient with this device experienced exposure, erosion, ongoing pain, mixed incontinence, urge incontinence, stress urinary incontinence, discomfort and burning sensation after voiding, hypermobile urethra, tenderness over right lateral urethra.On (b)(6) 2018 patient had a cystoscopy with excision of urethral device.Intraoperative findings included a 1:1 cm of completely exposed midurethral device.On (b)(6) 2020 patient had cystoscopy and placement of another manufacturer's midurethral device under general anesthesia.
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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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