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, impairment of sexual function, impairment of bowel and bladder function, recurrent urinary tract infections, disability, impairment of mobility, depression, anxiety, pain in pelvis, groin, thigh, rectum, and vagina.
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Additional information received on 10/29/2022 as follows: patient is experiencing urinary retention, dysuria, a mild weakness of the right lower extremity, vaginal spotting and itching.
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