Initial emdr is being re-submitted per request of fda on 03-may-2021.Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on 28-sep-2016 on 25-oct-2016, the following information was received: a batch record review found no discrepancies related to the reported complaint.Process checks and quality checks were performed and yielded acceptable results.No additional action is required and this complaint will be closed.The issue will be monitored through the post market monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on 11-nov-2016 (b)(4).
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