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.Patient mentioned that antibiotics was administered to subside the infection.However, patient did not provide any further information about the issue with the stitches that came unstuck.Patient was advised to reach out to hcp for medical assistance.
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