MAUDE Adverse Event Report: ALIGN TECHNOLOGY INVISALIGN; BRACES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Burning Sensation (2146); Urticaria (2278); Discomfort (2330); Numbness (2415); Polydipsia (2604)

Event Date 01/05/2015

Event Type  Injury  

Event Description

In the first week of (b)(6), i had invisalign braces put on my teeth.In the beginning, i noticed excessive thirst.I also noticed that food did not taste as good, not bad but tasteless.I thought this might to away with getting used to the braces.I also developed pain in my jaw, which i still have.Six weeks into using the braces, i developed hives around my eyes and cheek bone.I went to the dermatologist and she said i was having an allergic reaction, but we didn't know what i was allergic to.I did not tell her about the invisalign because i didn't think it was related.I have had dry burning eyes and wake up with swollen eyes and little pustules on the lids.About three days ago, i noticed that my nose and upper lip was numb.My tongue hurt, was swollen and extremely uncomfortable.Basically i was becoming miserable.I made another appointment with my dermatologist for tomorrow, (b)(6).Yesterday, (b)(6), i realized that probably i was having an allergic reaction to invisalign.I searched the internet and discovered that yes, this was an allergic reaction.Info gleaned from dental web sites and personal testimonies.Hundreds.I have been extremely uncomfortable almost the entire time of having these braces.I took off the invisalign trays yesterday and already my tongue is better.My upper lip and nose are less numb, but still numb.As far as the hives or bumps go, they are still there from earlier breakouts and i can't tell if there are new ones.There was no warning of any kind on the paper that came with the invasalign.This is a severe side effect and allergic reaction and if i had been warned, i would have removed them with the first symptoms.Please investigate this.

• Brand Name: INVISALIGN
• Type of Device: BRACES
• Manufacturer (Section D): ALIGN TECHNOLOGY
• MDR Report Key: 4577830
• MDR Text Key: 5561529
• Report Number: MW5041265
• Device Sequence Number: 1
• Product Code: NXC
• 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: 03/01/2015

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
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2015
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 54