H4: the lot was manufactured between december 9, 2022 ¿ december 13, 2022.H10: the actual device was received for evaluation.Visual inspection on the returned unit noted fluid contained inside the housing.Further inspection revealed the cause of fluid inside the housing was due to missing upper film-wrap.The upper film-wrap is located at the upper area of the bladder.The upper film-wrap fastens the bladder to the stressmember.When the film-wrap is missing, the bladder does not inflate during fill and the fluid leaks inside the housing.The reported condition was verified.The cause of the missing film-wrap was related to a manufacturing issue.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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