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 recurrent urinary tract infections about every 2 months, chronic pelvic pain, urethral stricture or narrowing, device exposure, bladder pain, urgency, frequency, dyspareunia, pelvic and perineal pain, dysuria, difficulty urinating, vaginal pain, stress urinary incontinence, chronic urethral / device pain, and scar tissue.The patient had the device explanted, cystourethroscopy, a pfannenstiel counter incision and suprapubic exploration under general endotracheal anesthesia.Pathology results included a foreign-body giant cell reaction, three tan-pink, irregular mucosal soft tissue fragments ranging from 0.4 x 0.3 x 0.1cm to 3.5 x 1.0 x 0.3 cm.A single blue suture extending from the largest fragments 3.5 cm in length was also noted.
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