MAUDE Adverse Event Report: INVISALIGN/ ALIGN TECHNOLOGY, INC. INVISALIGN TRAYS; ALIGNER, SEQUENTIAL

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

Patient Problems Dyspnea (1816); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Swelling/ Edema (4577)

Event Date 12/21/2020

Event Type  Injury  

Event Description

Difficulty breathing; started invisalign treatment on (b)(6) 2020.After treatment started, i developed hives, itching, redness, swelling and difficulty breathing.Ended up in er needing steroid shot, rx given for inhaler and steroid.Given epi pen just in case.Did not know reaction was from invisalign trays yet.I decided to do research online and found others who are allergic to invisalign.I decided to stop wearing the trays and noticed my allergic reactions all slowly going away over the course of 4 days.Fda safety report id # (b)(4).

• Brand Name: INVISALIGN TRAYS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): INVISALIGN/ ALIGN TECHNOLOGY, INC.
• MDR Report Key: 11228902
• MDR Text Key: 228872252
• Report Number: MW5098984
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/21/2021

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR