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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According to the available information, a (b)(6) patient experienced fever not related to infection and pain after virtue procedure.Date of procedure: (b)(6) 2018.Description of the event: from (b)(6) 2018, patient was hospitalized because of pelvic pain and fever.Patient didn't have any local signs.He had an antibiotics treatment with augmentin (amoxicilline and acide clavulanique) during 3 days because investigator thought that these symptoms can be related to his antecedent cystitis.72h after hospitalization, bacteriology test and blood culture were negative, so patient stopped antibiotics.Patient took also paracetamol for his pain.The symptoms improved during one week.Investigator doesn't know if this event is related to procedure.(virtue is still implanted).
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