H4: the lot was manufactured from may 20, 2021 - may 21, 2021.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was visually inspected and showed evidence of a bladder ruptured in a footing position.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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