Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.(b)(6) has been used as a default.The initial reporter also notified the fda on (b)(6) 2021.Medwatch report # mw5103138.Report source other: medwatch report.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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 monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: no root cause can be determined as no samples were received.Rationale: capa not required at this time.
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