(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation: pictures were received for evaluation and the following was observed: upon visual inspection of picture 3 the image shows a box with product code, lot number and expiration date not visible.The packaging qr was scanned, and the information was obtained.The lot number obtained from the qr codes, was entered in our system and the lot number, manufacture date, and expiration date was found with the product code belonging to another product.The discrepancy in the qr code on the package of image 3, where it belongs to another product code, concludes that this is a confirmed counterfeit.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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