H4: the lot was manufactured between january 27, 2023 to january 28, 2023.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph observed a ruptured bladder.The reported condition was verified.The cause of the 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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