H4: the lot was manufactured between february 16, 2023 and february 17, 2023.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph observed a pool of fluid inside the device housing which suggested a possible bladder rupture.The reported condition was verified.The cause of the condition could not be determined; however, a potential cause for 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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