During processing of this complaint, attempts were made to obtain complete patient information.A "demo product" was not confirmed and further follow-up indicates the packaging was intact and was not labeled as "not intended for human use." no devices were returned for evaluation.As a result, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances present that could have contributed to this issue.Additionally, review of records indicates this device was sterilized and is a finished good for human use.The device was incorrectly denoted as "demo" in sap/sales force during billing.Based on the information received, the device was in conformance at shipment and is in fact a device manufactured for human use.
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