H4: the lot was manufactured from september 23, 2021 - september 24, 2021.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph which showed 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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