(b)(4).Review of the device history records show that the lot was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report 2 of 7 for the same event.Reports 1, and 3 through 7 are reported on mfr #0001032347-2016-00235, and 0001032347-2016-00237 through 0001032347-2016-00241.
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This follow-up report is being submitted to relay additional information.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2016-00235-1, 0001032347-2016-00237-1, 0001032347-2016-00238-1, 0001032347-2016-00239-1, 0001032347-2016-00240-1, and 0001032347-2016-00241-1.
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