Additional information was added to d9, h3, h4, h6 and h10.H10: the device was received for evaluation.Visual inspection revealed that the bladder was ruptured.The ruptured bladder was examined to identify any issues that could have caused the rupture.No signs of abnormality were observed.The reported condition was verified.The cause of the condition could not be determined; however, 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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