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 2020-01-28 for INVISALIGN ALIGNERS manufactured by Align Technology, Inc..

Event Text Entries

[177146875] I began invisalign aligners on (b)(6) 2019 and immediately noticed a bad taste. When i woke the next morning, the taste was worse. I discovered all food and beverages tasted off too. I thought the problem was, perhaps, the chemicals used to apply the attachments and would dissipate but the taste was so bad! I called my orthodontist? S office on the morning of (b)(6) 2019 and was instructed to stop the invisalign aligners and referred to dr. (b)(6), an oral medical specialist, (b)(6)? I saw dr. (b)(6) on (b)(6) 2019 ((b)(6)). Dr (b)(6) prescribed an oral rinse, 4 times daily ((b)(6)). I kept the aligners out of my mouth until starting the? Alternate? Invisalign aligners on (b)(6) 2019. My tastebuds continued to be off through the entire holiday season. I lost 10 pounds because i could barely eat anything. Every time i put the? Alternate? Invisalign aligners in my mouth, the taste problem returned. I continued to put the? Alternate? Invisalign aligners in my mouth on and off until beginning 3m clarity on (b)(6) 2020, just to make sure my teeth didn? T move and the clarity aligners would fit. As instructed, i followed up with dr. (b)(6) on (b)(6) 2019 ((b)(6)). He was at a loss and prescribed lozenges. I had trouble finding a pharmacy that carried the lozenges and since i knew the solution was to keep the aligners out of my mouth, i did not fill the prescription. I returned all the original invisalign aligners to my orthodontist. I do have one set of the? Alternate? Invisalign aligners. I was told the? Alternate? Aligners are cleaned manually without the use of chemicals used to clean the regular invisalign aligners. Note: i began 3m clarity aligners on (b)(6) 2020 and have not had the same problem. I saw an oral medical specialist in (b)(6) and (b)(6) and spent 7 weeks rinsing my mouth 4 times a day with the prescribed medication. During this time, i ate to survive. Everything i put in my mouth tasted horrible. I lost 10 pounds. Please see the paragraph above regarding what i have in my possession to provide to the fda. I asked my orthodontist to report my adverse event to the fda also. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092568
MDR Report Key9641516
Date Received2020-01-28
Date of Report2020-01-24
Date of Event2019-11-19
Date Added to Maude2020-01-29
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 NameALIGNERS, SEQUENTIAL
Product CodeNXC
Date Received2020-01-28
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerALIGN TECHNOLOGY, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2020-01-28

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