Correction made to b3 event date: 11/09/2022 (previously submitted as 09/09/2022) h4: the lot was manufactured from october 20, 2021 - october 21, 2021.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph and a ruptured bladder in a footing position was observed.The reported condition was verified.The cause of the condition could not be determined.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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