The initial reporter also notified the fda on (b)(6) 2020.Medwatch report # (b)(4).Report source other: medwatch report (b)(4).Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.Rationale: customer complaint trends are evaluated on a monthly basis, however the need for a formal corrective action cannot be determined in the absence of the root cause.
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