H4: device manufactured on may 4, 2021- may 5, 2021.H10: the device was received for evaluation.Visual inspection revealed that the bladder was ruptured.The ruptured bladder was further 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 was not determined; however, 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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