This report is being submitted retrospectively as part of an internal review.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.The sensor is inserted by making a small incision and placing it under skin and potential for developing skin irritation/inflammation/infection at the insertion site is a known anticipated adverse event.Furthermore, the patient visited doctor who cut open the incision place, put out the pus and gave insolan ointment to treat the infected area.
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On october 2, 2020, senseonics was made aware of an instance where a patient noticed redness, itching, and an abscess developing at the insertion site.The former sensor had been inserted on the left arm.The doctor cut open the incision place, drained the abscess and gave the patient ointment.
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