H4: the lot was manufactured from may 21, 2019 ¿ may 22, 2019.H10: the actual device was not available; however, two (2) photographs of the sample were provided for evaluation.The returned photographs were reviewed, and it was noted that the reported condition is not clearly observed via the provided photographs.Due to the nature of the returned sample no additional testing could be performed.Therefore, the reported event could not be objectively verified.The cause of the reported condition could not be determined.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.
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