INVISALIGN ALIGNERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for INVISALIGN ALIGNERS manufactured by Align Technology, Inc..

Event Text Entries

[181772267] I began invisalign on (b)(6) 2020 and noticed dry mouth, sores in the mouth and on the tongue within the first week of use. I thought this was normal since i never had used the product before. When i started my second set of trays on (b)(6) 2020, that is when i started experiencing severe sinus pain on my right side, severe dizziness that sent me to urgent care (they put me on anti-biotics thinking it was a sinus infection because i had barotrauma to left ear. But the dizziness, nausea, hot and cold chills with no fever, dry cough, stomach pain, difficulty swallowing or feeling like i constantly have something stuck in my throat and serious fatigue were still present. I also had no appetite and have gas and burping whenever i drink liquids of any kind. I decided on (b)(6) 2020 to go to the er because my stomach pain moved to my right side and would enflame after eating. They did several blood tests and ultrasound of the affected area and they said it all looked normal and sent me home. So later that night i decided to take the trays out since that is the only thing that had changed in my life since i got so ill. Within 30 minutes of taking them out my sinus pressure and pain went away and so did the severe neck pain. Over the last several days i have slowly started to feel better, but a lot of my symptoms are still present. The safety data sheet on the aligners provided to me by my orthodontist doesn? T show the composition of the aligners. He tried getting more information but all he was given was that they are made of thermoplastic polyurethane, bpa free, latex free and washed ionized water after manufacturing. I am also experiencing difficulty sleeping as i wake up several times in the night and have to swallow. I can? T stay in a rem sleep due to whatever it is i? Ve been exposed to. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093425
MDR Report Key9775132
Date Received2020-02-28
Date of Report2020-02-27
Date of Event2020-02-10
Date Added to Maude2020-03-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINVISALIGN ALIGNERS
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-02-28
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerALIGN TECHNOLOGY, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-28

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