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Model Number SC1200 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Headache (1880); Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/14/2020 |
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 the complaint handling procedure to ensure compliance with fda regulations.These improvements were recommended because of an internal audit conducted by an external independent regulatory consultant.Soclean opened several capas to remediate the audit findings.Processes were revised to ensure reportable events were correctly identified and submitted to fda.Per fdas guidance, soclean is now reporting these events, which also includes retrospective items.
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Event Description
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Customer reports headaches, dizziness and inner ear infection with md intervention requiring treatment plan.
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Search Alerts/Recalls
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