File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.A clinical investigation was performed.The customer states preexisting sinusitis with multiple diagnosis of covid19.It is unclear what the cause of the sinus infections is.It is not unreasonable to assume that the customer's symptoms/diagnosis are due to preexisting medical conditions.In addition, the customer did not mention the use of the soclean to the md.He continues to use the device without further reported issues.Reporting for due diligence.
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