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, the patient with this device experienced dyspareunia, vaginitis, severe pelvic pain, urinary urgency, urinary incontinence, device exposure through the vaginal wall, abnormal bleeding, loss of ability to perform sexually, physical deformity and difficulty with daily activities.She had an additional surgeries to explant the device.Patient also experienced severe emotional pain and anguish.
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