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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
Dyspnea (1816); Inflammation (1932); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/30/2022 |
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.
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Event Description
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Customer reports congested sinuses, shortness of breath and inflammation.Md was seen and prescribed antibiotics, steroid nasal spray, oral steroids and has his sinuses flushed.
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Search Alerts/Recalls
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