This report is being submitted retrospectively as part of an internal review.The device was not defective.The sterilization record for this lot of sensor was reviewed and the sensor was sterilized as per specifications.The potential to develop reactions at the insertion site is a known and anticipated adverse effect of the system.There is no remedial action/corrective action/preventive action/field safety corrective action required in this case as the device is not defective.The potential to develop reactions at the insertion site is a known and anticipated adverse effect of the system.The patient visited the healthcare facility and they decided to remove the sensor on his request.
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