(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A query was run on december 07, 2017 against lot number 7g02033 for the reported event, and yielded 1 occurrence (s) against the lot.At this time, a detailed investigation or batch review is not required.If additional complaints occur with the batch criteria and same reported event, any subsequent complaints shall be assessed for further investigation.This issue will be monitored through the post market product monitoring review process. to date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
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