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Model Number SC1200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Fungal Infection (2419); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/29/2020 |
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 lung infection, ear infection, sinusitis, trouble swallowing and mucous with md intervention requiring antiobiotics, mouth wash and a bronchodilator and a ct of his sinuses finding benign growths.
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Search Alerts/Recalls
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