H4: the lot was manufactured from manufactured october 20, 2021 to october 21, 2021.H10: the actual device was received for evaluation.A visual inspection on the returned unit with the naked eye noted the bladder had been ruptured.The ruptured bladder was examined for signs of abnormality.There were no signs of abnormality found on the bladder that may have led to the rupture.The reported condition was verified.The root cause could not be determined.A possible root cause for the bladder rupture may be due to inherent variation in the material, 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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