(b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the photographs did not identify any abnormalities that could have contributed to the reported condition.The reported condition could not be verified through evaluation of the photographs.Should additional relevant information become available, a supplemental report will be submitted.
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