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.To alleviate the symptoms reported by the patient, the doctor decided to remove the sensor from the arm.No medication was prescribed.The patient is doing fine and will be re-inserted with a new sensor to continue using eversense system.No further investigation was found necessary this complaint.
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