End user states multiple symptoms with an unknown source.It is unclear the source of his conditions but it is not likely to be related to our device.Customer refuses to return device to allow for testing, unable to trace to our device.Continue to track and trend for increased incidence.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.
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Customer reports a right side only - dry burning irritation in the throat, sinus infections, difficulty swallowing, irritation behind the eye with slight hearing loss of right ear and ringing in the ear, with md intervention requiring a ct scan that was negative, and antibiotics that improved symptoms slightly the customer refused to return the device.
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