As reported to coloplast, though not verified, legal representative stated the patient with this device experienced trigger point injection and cystoscopy with urethral dilation, pelvic/perineal pain, dysuria, urinary urgency with frequency and nocturia, severe pain of the urethra around the site of the device, bladder outlet obstruction secondary to device, and small erosion of the device.Patient had transvaginal explantation of the device and urethrolysis under general anesthesia.Intraoperative findings noted exposure of the device approximately 2.5 cm inferior to the urethral meatus and the right side of the device was noted to be significantly tethered with scar tissue and a palpable lump.Surgical pathology noted a fragment of clear tan mesh¬ like plastic with small portions of adherent pink, tan tissue measuring 0.5 x 0.2 x 0.1 cm.
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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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