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.The item number and lot number are not known.
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As reported to coloplast, though not verified, legal representative stated the patient with this device experienced severe pelvic pain, back pain, severe abdominal pain, pain with sitting, bleeding, cramping, device exposure, dyspareunia, urinary urgency problems, infections, discharge, difficulty with daily activities and underwent two explantation surgeries.
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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.The item number and lot number are not known.
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