Model Number SC1200 |
Device Problems
Defective Component (2292); Insufficient Information (3190)
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Patient Problems
Viral Infection (2248); Skin Burning Sensation (4540); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/28/2024 |
Event Type
Injury
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Event Description
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Customer reports burning sensation in throat and on nose.Diagnosed viral infection in throat.Swelling of throat causing difficulty breathing.Customer went to the emergency room and received antibiotics.All other tests performed were negative which include a ct scan, covid test, strep test and a chest x-ray.
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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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Manufacturer Narrative
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During the packaging of this submission, it was discovered that the eval number initially referenced was incorrect due to a transposition error.The correct eval number for this complaint is (b)(4)., which was mistakenly reported as (b)(4).
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Search Alerts/Recalls
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