The device was manufactured from july 27, 2021 - august 3, 2021.The actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photograph was performed which observed a ruptured bladder.Due to the nature of the sample, no additional testing could be performed.The reported condition was verified.The cause of the condition could not be determined; however, the possible root 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.
|