As reported to coloplast, though not verified, the patient with this device experienced bacterial vaginosis, device exposure, mixed urinary incontinence, increased discharge, nocturia, urinary urgency, urinary frequency, vaginal bleeding occasionally when wiping, and grade iii cystocele and uterine prolapse.It was noted that patient experienced symptoms related to a urinary tract infection that included burning with urination and pain in the back and side.Significant other reported that he felt something poking him during sexual activity.Procedures included laparoscopic supracervical hysterectomy with sacrocolpopexy using y-graft, bilateral salpingectomy, adhesiolysis, implantation of another manufacturers device and excision of anterior vaginal wall device.Intraoperative findings from the procedures included device erosion to the anterior vaginal wall, anterior wall adhesions.The left fallopian tube was adherent to the bowel.Pathology follow up for uterus and tubes.
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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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