H4: the lot was manufactured from july 16, 2020, to july 17, 2020.H10: the device was received for evaluation.A visual inspection with the naked eye was performed which noted that the bladder had been ruptured.The reported condition was verified.The ruptured bladder was examined for the following signs of abnormality.There were no signs of abnormality found on the bladder that may have led to the rupture.The cause of the condition could not be determined; however, possible root cause for the bladder rupture may be due to inherent variation in the material, as bladders were 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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