Additional information: d9, h3, h6, h10.H10: three (3) actual devices were received for evaluation.Visual inspection was performed and the primary package was observed damaged.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to storage, shipment, and/or distribution of the product.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|