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.
|
Comiter cv, rhee ey, tu lm, herschorn s, nitti vw.The virtue sling--a new quadratic sling for postprostatectomy incontinence--results of a multinational clinical trial.Urology.2014 aug;84(2):433-8.Doi: 10.1016/j.Urology.2014.02.062.Epub 2014 jun 25.Pubmed pmid: 24972946.According to the available information, of 98 patients implanted, one patient experienced a urinary tract infection and one patient experienced a scrotal hematoma.Both events required readmission.
|