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Model Number SC1200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Headache (1880); Sore Throat (2396); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/26/2019 |
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 headaches, sore throat, sinus dripping, and chest pain with md intervention recommending discontinued use of the device.
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Search Alerts/Recalls
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