Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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.
|
As reported to coloplast, though not verified, the patient with this device experienced vaginal pain, aggravated by intercourse.It was noted that there was foreign material in vagina and urethral scarring.Therefore, removal of the vaginal sling was performed, along with removal of vulvar mesh with exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection and mesh removal from the deep obturator internus muscles and anterior colporrhaphy.This was a very difficult surgery due to scarring from the previous surgery and the dissection required to remove the mesh from the from the groins that was very deeply implanted especially on the right.The sling was tight at the bladder neck and was flat but folded laterally.The entire sling was removed.
|