MAUDE Adverse Event Report: ALIGN TECHNOLOGY INVISALIGN ALIGNERS

Model Number	7096015
Health Effect - Clinical Codes	Diarrhea (1811); Headache (1880); Nausea (1970); Swelling (2091); Blurred Vision (2137); Vomiting (2144); Burning Sensation (2146); Dizziness (2194)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
I just received my invisalign aligners on thursday, (b)(6) 2018 and after i put them in while at the orthodontist, i started feeling strange sensory experience, like a migraine aura.Trying to ignore it, i put them in and out a few times to learn the process.I got out of the chair and was dizzy and had blurred vision.I went to a sink where i did a fluoride rinse (never had adverse reaction to fluoride before) and spit it out.I put the aligners in and went up to make my next appointment.Felt strange and then my mouth started watering and i was nauseous and i asked for a bottle of water.I drank half and had to run to the bathroom to vomit.I took the aligners out.I was still very nauseous, i asked the lady if it was a side effect and she thought maybe it was from the fluoride rinse.I grabbed another bottle of water and some napkins and went to the parking lot where i proceeded to have nausea, drool and continued to heave.I had the nausea and disorientation for about another hour or two.Later that evening i thought i'd try the aligners again.I felt tired and nauseous, got sweats and goose bumps and had digestive issues.I slept in the aligners and in the morning still felt sick.I noticed my eyes were burning and swollen.Took them out and washed them with a retainer brite tablet.I kept them out and started to feel a little better about 4 hours later, although still nauseous.I put them back in and i continued to have digestive issues, gas, burping, headache, tiredness, nausea, ears ringing, sweats and chills and just an over all ill feeling.I spent the day pretty much in bed.I rinsed the aligners and brushes my teeth throughout the day.Before bed i used eversmile whitening foam in them.This morning i am still nauseous like when i was pregnant.Smells like certain food and cigarette smoke make me sick.It is humid outside and it feels especially hard to get my breath outside.I still have the above symptoms and now add diarrhea.It is a weekend (saturday), so i decided to take them out, clean them with the retainer brite tablet again and quit wearing them until i can call my orthodontist on monday and see what he thinks.I totally relate these problems to the aligners, because i was feeling fine and energetic before i got them and instantly started feeling sick when i put them in and have been sick ever since.Every time i take them out for a few hours and start feeling a bit better, i try them again and my symptoms are worse again.I did get fibromyalgia following many reconstructed breast surgeries, with implants, after a mastectomy.It makes me wonder if the aligners and the implants are made of some of the same materials and i have a sensitivity or allergy to it.

• Brand Name: INVISALIGN ALIGNERS
• Common Device Name: INVISALIGN ALIGNERS
• Manufacturer (Section D): ALIGN TECHNOLOGY
• MDR Report Key: 7568663
• Report Number: MW5077610
• Device Sequence Number: 2019188
• Product Code: NXC
• UDI-Device Identifier: 00816063020004
• UDI-Public: (01)00816063020004
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 7096015
• Device Catalogue Number: (10) 0036744782
• Device Lot Number: (13) 180517
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 51 YR
• Patient Weight: 64