H4: the lot was manufactured from november 05, 2021 - november 08, 2021.H10: the device was received for evaluation.A visual inspection performed using the naked eye found the bladder had been ruptured.The ruptured bladder was examined for signs of abnormality that may have potentially caused the rupture problem.No signs of abnormality were found.The reported condition was verified.The cause of the condition could not be determined; however the most probable cause is manufacturing related.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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