H4: the lot was manufactured from march 28, 2023 - march 29, 2023.Correction made to d4: catalogue #: d2c4711k (previously submitted as 2c4711k).Correction made to d4: lot#: 23c017 (previously submitted as 22n020).Correction made to d4: udi#: (b)(4) (previously submitted as (b)(4)).The device was received for evaluation.A visual inspection with the naked eye was performed and a ruptured bladder was observed.The ruptured bladder was examined and there were no signs of abnormality found on the bladder that may have led to the rupture.The reported condition was verified.The cause of the condition could not be determined; however, a possible cause 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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