Model Number INVISALIGN SYSTEM - COMPREHENSIVE |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 01/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptom.This event is being filed as an mdr as the patient was prescribed an epipenand the invisalign product was being used.A udi could not be provided in this report as this information was not captured in this complaint ticket.
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Event Description
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The patient reported the symptom of swollen tongue and closed throat.The patient reported visiting a physician to alleviate the reported symptoms.The patient reported being prescribed an epipen (epinephrine) to alleviate the reported symptoms.The treatment was discontinued on (b)(6)2022 and the patient is currently getting better.The treating doctor shared the potential root cause could have been a reaction to the aligners.
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Search Alerts/Recalls
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