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Model Number SC1200 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Dyspnea (1816); Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/27/2021 |
Event Type
Injury
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Event Description
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Customer reports congestion, dizziness, vertigo, dyspnea with md intervention requiring discontinued use of the soclean device, medications, steroids and an inhaler.
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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 disputes the statements made by philips related to ozone and the philips recall.We will maintain a record of your injury.Please consult with your physician or a medical professional if your injury continues.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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Search Alerts/Recalls
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