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Model Number SC1200 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Sore Throat (2396); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/27/2022 |
Event Type
Injury
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Event Description
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Customer states sore throat and flu-like symptoms, md was seen and prescribed antibiotics.Customer does not perform regular maintenance cleaning of the cpap equipment as stated in our ifu.
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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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Search Alerts/Recalls
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