MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN CLEAR BRACES- TRAYS; ALIGNER, SEQUENTIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Discoloration (2074); Tachycardia (2095); Arthralgia (2355); Cognitive Changes (2551); Swollen Lymph Nodes/Glands (4432); Blister (4537); Swelling/ Edema (4577)

Event Date 10/16/2022

Event Type  Injury  

Event Description

Today at the er they had to reset my heart using adenosine because it was sitting at 209 (heart rate) because of the invisalign tray reactions i am experiencing to their material.I was unaware the possibility of the material they use to make the tray's polyurethane could cause one severe adverse reactions.I have had invisalign trays - made by align technology by a manufacturer in mexico in for 6 months - two weeks after getting them in my doctor have been trying to figure out was wrong with me, waking up with migraines, extreme fatigue, extreme joint pain, swollen glands, swollen lymph's on october 10 - which progressed into my whole face swelling; white hard blisters in my lips, nasal cavities, swollen shut, heart palpitation.I went to the er on saturday, (b)(6) after discovering that my invisalign trays were causing me a severe adverse reaction.I had full face swelling blisters in the labs, tongue, swelling, i swelling, lymph node swelling, difficulty breathing, heart palpitations, migraine, extreme fatigue, brain fog.The er doctor prescribed me 50 mg of prednisone i had removed the invisalign trays on tuesday night (b)(6).Saw my dentist wednesday, (b)(6) 20022.The swelling was bad but persisted to get worse within my actual mouth and lips and lymph nodes.I am on my fourth day of 50 mg prednisone and the swelling has started to recede but the blistering which is in my lips and inside my jaw tissue is persistent, and er doctor said it could take weeks for this to subside due to the duration of exposure from the invisalign trays, which has been six months, and he could not tell me when i may return back to normal.When i first put the invisalign in, i started to experience headaches had some swelling, but it would come and go as the months went on.I started to experiencing migraines severe upon waking up, severe, chronic fatigue, severe joint pain severe brain fog i was sleeping 12 to 14 hours a day.It has totally disrupted my life.My doctor has categorically logged all of these issues because we have done blood test and allergy test to try and figure out what the problem was in the whole time.The problem was the invisalign tray , i have done research and found hundreds and hundreds and hundreds of other documentations of experiences like mine or worse.The invisalign client agreement does not disclose any of these severe reactions being a possibility my dentist was totally unaware of any of these adverse reactions being an issue, and on the website, they do not disclose any type of adverse reactions.Had i had the knowledge to know that these symptoms were caused by the invisalign i could've ended my treatment much sooner and save myself months and months of pain and suffering.I understand that the fda gave invisalign online technology a warning in 2011 about non-disclosure and non-transparency of severe adverse reactions in their patients.I paid $(b)(6) out-of-pocket, and i am waiting to hear from invisalign about a full refund.But why they have not disclosed these possible.Reactions in their literature on their website is confusing as if i had the knowledge i could've stopped the treatment much sooner.I am waiting on my toxicology reports.Fda safety report id# (b)(4).

• Brand Name: INVISALIGN CLEAR BRACES- TRAYS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 15638587
• MDR Text Key: 302200159
• Report Number: MW5112756
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADENOSINE
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 49 YR
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White, American Indian Or Alaskan Native