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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
|
As reported to coloplast, though not verified, mesh palpable at apex and anterior vaginal wall, pelvic pain.On (b)(6) 2013- mesh erosion with adherence to sigmoid colon.No other adverse patient effects were reported.
|