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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As reported to coloplast, though not verified, legal representative stated the patient with this device experienced occasional leakage when standing, persistent pelvic pain, recurrent stress urinary incontinence, deep dyspareunia, husband felt something sharp during intercourse, right sulcus device exposure, exposure of suture at incision site, right sided discomfort in the vagina when sitting in the car, left side of device and left anchor are palpable and tender with reproducible pain, left obturator spasm, and pain with intercourse that is positional.Patient had a device revision in 2018.Patient had another device revision and cystoscopy under monitored anesthesia care in 2019.
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