As reported to coloplast, though not verified, legal representative stated the patient with this device experienced dyspareunia, pelvic pain, vaginal pain, recurring urinary incontinence, recurring urinary tract infections, depression, anxiety, severe permanent pain, disability, impairment of mobility, impairment of bowel and bladder function, impairment of sexual function, and future explantation of the device.The patient was diagnosed with pudendal neuralgia and underwent explantation as well as pudendal nerve blocks, and is receiving ongoing medical treatment for her injuries.Patient suffered from pre-existing injuries or conditions which were aggravated, exacerbated, and/or accelerated by implantation of the device.
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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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