Model Number INVISALIGN SYSTEM - COMPREHENSIVE |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Date 04/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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No conclusive evidence has been provided that supports or opposes that fact that the invisalign system aligners caused or contributed to the patients symptoms.This event is being filed as an mdr as this event appears to have been serious in nature or life threatening to the patient and an align product was being used.
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Event Description
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The patient reported symptoms of sensation of throat closing and difficulty breathing.The patient reported visiting the er to alleviate the reported symptoms.The patient reported being prescribed epinephrine and benadryl to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2019 and the patient is currently getting better.
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Search Alerts/Recalls
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