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Model Number SC1200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Rash (2033); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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Customer reports a skin irritation, breakout on cheeks and sores inside nose, burning sensation on skin with md intervention requiring topical cream and oral medication.
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Search Alerts/Recalls
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