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 available information, the patient with this device experienced infection, septic fever of 40 degrees celsius, and hospitalization on 3 occasions.The first time the patient was hospitalized was in (b)(6) 2021 for 10 days.Also hospitalized in (b)(6) 2021 and (b)(6) 2022.The dates occurred are approximate.All of the catheter placements have taken place in the patient's home.Microbiology tested the patient's urine and device, and they thought infection was on the device.Patient is worried about the sterility of the devices and about future infections.Patient suffers from infection and cellulitis.
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