Model Number SC1200 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Bronchitis (1752); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/18/2022 |
Event Type
Injury
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Event Description
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Customer reports a cough and phlegm secondary to bronchitis diagnosis x2.Md seen, prescribed amoxicillin and unspecified second prescription.The customer continues to use the device without further reported issues.
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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.The customer continues to use the device without further reported issues.The customer states that the bronchitis diagnosis has been relieved with prescribed antibiotics.It is not unreasonable to assume that the soclean 2 is unrelated to this diagnosis due to the customer continuing to use.Reporting this incident for due diligence.
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Search Alerts/Recalls
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