Additional information: the actual device was not available; however, photographs were provided for evaluation.The photographs only showed the packaging and not the sample itself.Visual inspection therefore could not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified due to the nature of the sample.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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