File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.The customer's symptoms did not subside after discontinued use of the soclean2 therefore, it is unlikely that the sc contributed to the customer's reported symptoms.The customer states he had ozone poisoning, however no tests were performed by a medical professional to determine the validity.The device passed all functional testing, and was performing as designed.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.
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