Model Number SC1200 |
Device Problem
Decrease in Pressure (1490)
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Patient Problem
Fungal Infection (2419)
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Event Date 02/02/2022 |
Event Type
Injury
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Event Description
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Customer reports a yeast infection in throat, md prescribed mizonazole to treat the infection.In addition the customer was not properly handwashing the device according to 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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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 a yeast infection in throat, md prescribed mizonazole to treat the infection.In addition the customer was not properly handwashing the device according to our ifu.
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Search Alerts/Recalls
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