As reported to coloplast, though not verified, legal representative stated the patient with this device experienced difficulty urinating, has to bend forward in order to urinate, leg pain, left groin pain, left thigh intramuscular abscess, recurrent groin abscess, pyomyositis, purulent discharge from vagina, bloody discharge from vagina, malodorous drainage from vagina, left medial thigh abscess with tract through the left obturator canal to the lateral aspect of the vagina, sepsis, and acute kidney injury.Patient had pooling of fluid in left groin and concern for fistula from anus to vagina.No fistula noted on exam however right vaginal device erosion noted.Patient had a revision of vaginal device under general anesthesia.Patient also had an exam and exploration of penetrating wound of left extremity under general anesthesia.
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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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