Correction b3: the events occurred on unspecified dates ¿within the week of (b)(6) 2020 to (b)(6) 2020 (omitted on initial).H10:the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.The reported condition is not clearly observed via the provided photographs and due to the nature of the returned sample no additional testing could be performed.Therefore, the reported problem could not be verified or refuted.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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