Model Number INVISALIGN SYSTEM - MODERATE |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Chest Pain (1776)
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Event Date 12/01/2021 |
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 reported the symptom of chest pain and there was no conclusive evidence that the invisalign product was not related to the event.
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Event Description
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The patient reported symptoms of chest pain and stomach issues.The patient reported visiting a specialist and was diagnosed with severe gastroparesis.The patient did not report taking or being prescribed medication to alleviate the reported symptoms.The treatment was discontinued on an unspecified date and the patient is currently getting better." the treating doctor shared the potential root cause could have been that the aligners exacerbated the condition.
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Search Alerts/Recalls
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