H4: device manufacture date: march 12, 2022 - march 14, 2022.The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed on the photograph which displayed fluid contained inside the bladder.The photograph suggested a leak condition may have occurred.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause were result of damage, improper solvent bonding, or product misuse.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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