Model Number INVISALIGN SYSTEM - COMPREHENSIVE |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Nausea (1970); Angioedema (4536); Swelling/ Edema (4577)
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Event Date 07/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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The current instructions for use (ifu) contains the following: "warning - in rare instances, some patient may be allergic to the plastic aligner material, discontinue use and consult a health care professional immediately." the potential root cause is unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused the reported symptom.This event is being filed as an mdr as the patient presented hereditary angioedema and the invisalign product was being used.
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Event Description
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The patient reported symptoms of blush, nausea, difficulty breathing and swollen eye.The patient did not report requiring any medical intervention to alleviate the reported symptoms.The patient reported being prescribed eye drops to alleviate the reported symptoms.The treating doctor reported that the patient presented evidence of hereditary angioedema (hae).The treatment was discontinued on (b)(6) 2022 and the patient is currently getting better.
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Search Alerts/Recalls
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