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Model Number SC1200 |
Device Problems
Decrease in Pressure (1490); Appropriate Term/Code Not Available (3191)
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Patient Problems
Bronchitis (1752); Rash (2033)
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Event Date 02/26/2021 |
Event Type
Injury
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Event Description
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Customer reports bronchitis, sinus infections , rash on nose & lips.Md seen.Received antibiotics, nasal spray, cough syrup, antifungal cream.
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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 believes this complaint is related to the philips recall of the dreamstation 1, not the soclean device.Soclean is processing this complaint in accordance with its complaint handling and quality system processes.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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