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 was unwilling to provide important details to determine root causes of his symptoms.It is important to note that the customer was unsure of dates related to the injury, therefore it was difficult for the complaint team to determine if the injury was caused by the soclean or not.Reporting for due diligence.Soclean believes this complaint is related to the philips recall of the dreamstation 1, not the soclean device.Soclean is processing this complaint in accordance with its complaint handling and quality system processes.
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