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- W2766573766 abstract "•We found 173 medical device reports related to Invisalign in the MAUDE database.•169 were designated as adverse events, and 45 were serious or life-threatening events.•Difficulty breathing (56 events) was the most common event reported.•Sore (35) or swollen (34) throat and swollen tongue (31) were reported.•Hives and itchiness (31), anaphylaxis (30), and swollen lips (27) were reported.•Serious life-threatening events could be associated with the use of Invisalign. IntroductionThe objectives of this study were to examine adverse clinical events after the use of the Invisalign system and to provide an overview of the actions taken by the manufacturer to address these events.MethodsA retrospective analysis of the Manufacturer and User Facility Device Experience database of the United States Food and Drug Administration was used. All medical device reports reported to the United States Food and Drug Administration pertaining to products of Align Technology from November 1, 2006, to November 30, 2016, were analyzed. Qualitative content analysis was conducted of event descriptions and manufacturer narrative reports.ResultsA total of 173 medical device reports were reported in the Manufacturer and User Facility Device Experience database: 169 (97.7%) were designated as adverse event reports, and 45 (26%) were deemed by the treating doctor to be serious or life threatening. The most medical device reports that reported a serious or life-threatening event were in 2014 (50%). The most frequently reported adverse event was difficulty breathing (56 events) followed by sore throat (35 events), swollen throat (34 events), swollen tongue (31 events), hives and itchiness (31 events), anaphylaxis (30 events), swollen lips (27 events), and feeling of throat closing/tight airway/airway obstruction/laryngospasm (24 events).ConclusionsSerious or life-threatening events could be associated with use of Invisalign systems. Health care providers should be aware of these events and know how to handle them if they arise in their practices." @default.
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- W2766573766 date "2017-11-01" @default.
- W2766573766 modified "2023-10-18" @default.
- W2766573766 title "Adverse clinical events reported during Invisalign treatment: Analysis of the MAUDE database" @default.
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- W2766573766 doi "https://doi.org/10.1016/j.ajodo.2017.06.014" @default.
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