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, the patient with this device experienced dysuria, minimal vaginal stenosis, bloody discharge, gradual onset sharp pelvic and vaginal pain that worsens with motion and intercourse, partner reported penile pain with intercourse and penile abrasion, intercourse tolerable with use of a condom, bacteria vaginosis, and recurrent urinary tract infections.Patient had possible device erosion visualized on anterior vaginal introitus, hematuria, positive urine culture for group b beta hemolytic strep, and previously diagnosed vaginal device erosion.Patient had partial explantation of device with vaginal tissue trimming / repair, diagnostic laparoscopy, and bilateral salpingectomy with left hydrosalpinx removal.Intraoperative findings found visualized device seen horizontally ~2 cm wide x 0.5 cm high.Also reported, urinary infection, dysuria, nocturnal enuresis, vaginal discharge, and patient unable to have intercourse due to pelvic surgery and bladder problems which lead to a stressful sexual relationship with spouse.Anterior erosion found with exam and partial scissor explantation of small amount of device from anterior vagina was completed in office.Bilateral anterior device erosion found with exam and partial scissor explantation of device from bilateral anterior vagina was completed in office.Device visualized lateral to urethra bilaterally on exam and vaginal tissue covered the blunt ends of the device and the device protruded into the vaginal cavity.Unable to trim device in office without causing significant bleeding, patient had partial explantation of the device.Interoperative findings found a small area of device protruding from the superior left side of the urethra.
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