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 severe abdominal and pelvic pain, recurrent incontinence, infection, prolapse, dyspareunia, and embedded device into rectal tissue.The patient also had a bladder resection due to device erosion into the bladder and vagina.It was noted that the device was trimmed and remains partially implanted due to fears of additional trauma to rectal tissues.
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