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Model Number SC1200 |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Swollen Lymph Nodes/Glands (4432); Unspecified Respiratory Problem (4464); Unspecified Ear or Labyrinth Problem (4474); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/13/2021 |
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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They have been to the md three times regarding sinus issues, respiratory issues and ear pain.Their lymph nodes are swollen and giving them problems.
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Search Alerts/Recalls
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