Additional information was added to d9, h3, h4, h6, and h10: h4: the lot was manufactured between april 11, 2023 ¿ april 13, 2023.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that the bladder had ruptured.The ruptured bladder was examined, and there were no signs of abnormality observed on the external and internal surfaces of the bladder, the rupture line and stressmember.The reported condition was verified.The cause for the 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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