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.Device not returned.
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As reported to coloplast, though not verified, product type unknown.(b)(6) 2006- recurrent stress urinary incontinence ¿¿sling may have loosened after her cough incontinence episode¿, palpable urethral sling.(b)(6) 2006- significant stress incontinence, (b)(6) 2006 - stress incontinence, (b)(6) 2006- autologous pubovaginal sling placement under general anesthesia, 2010- unknown pelvic surgery, (b)(6) 2021- mesh exposure, rectocele, excision of exposed vaginal mesh, removal of perforated mid urethral sling, urethroplasty, cystoscopy.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.
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