E1: (b)(6).H4: device manufacture date: lot 22k016 was manufactured from october 14, 2022, to october 17, 2022.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was noted that it showed evidence of a ruptured bladder.The reported condition was 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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