Additional information was added: the lot was manufactured from april 11, 2019 - april 12, 2019.The actual device was not available; however, a photograph of the sample was provided for evaluation.The provided picture was too dark and blurry to properly evaluated the reported condition.Therefore, the issue could not be confirmed nor refuted.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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