(b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided pictures did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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