H4: the lot was manufactured between april 11, 2022 to april 13, 2022.H10: one actual device was received for evaluation.A visual inspection was performed, and it was noted that the bladder was ruptured.The ruptured bladder was examined for signs of abnormality and no signs of abnormality were observed on the external and internal surfaces of the bladder.The reported condition was verified.The cause of the reported condition could not be determined; however, possible root cause for bladder rupture may be due to inherent variation in the material from manufacturing, as bladders are manufactured with rubber.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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