Senseonics was made aware of an incident where patient reported infection at the insertion site.On the (b)(6) 2022 from the insertion site on the patient's arm, it started to excrete pus; when the patient pinched lightly the insertion site to understand what was going on, other than more pus, the sensor itself popped out of the patient's arm.Patient was treated with augmentin tablets.
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This report is being submitted retrospectively as part of 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/swelling/pain/ inflammation/infection around the insertion site is a known anticipated adverse event.No further investigation was necessary for this complaint.Since the sensor popped out and was nearing expiration, patient decided to make an appointment with the doctor for new insertion in the opposite arm.Furthermore, the doctor prescribed augmentin tablets to treat infection.
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