File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Soclean has reviewed and made improvements to our complaint handling procedure to ensure compliance with fda regulations.These improvements were recommended as a result of an internal audit conducted by an external independent regulatory consultant.We revised our decision trees and re-evaluated retrospective complaints to ensure reportable events were correctly identified.Per fdas guidance soclean is now reporting these retrospective mdrs.In addition, soclean has opened several capa's to remediate the audit findings.A capa was opened by the company as a result of an independent internal audit that took place in february 2020.Capa-(b)(4) involved a retrospective review of all customer cases to determine if they met the definition of a complaint.There is a portion of complaints that were mis-categorized when they were created by customer care and at the time the determination was made that the complaints were not considered health related and/or potentially reportable.Therefore, these devices were not identified as needing functional and visual inspections.Given the scope and size of this retrospective project, it took a significant amount of time to review all of the cases and the devices we not identified timely and are no longer available for testing.Soclean still conducted an inspection of the details surrounding the complaints to the best of our ability and has reported anything that met the definition of reportable.
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