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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Nausea (1970); Swelling (2091)

Event Date 01/29/2019

Event Type  Injury  

Event Description

Insidious start of nausea, lack of appetite and abnormal taste in mouth after beginning orthodontic treatment with invisalign dental appliance.Devices were cleaned and brushed daily per dentist directions.Three weeks into treatment program, tongue became visibly swollen and lost feeling in lips.Given oral antihistamines and corticosteroid, orthodontic treatment discontinued, and as of today (feb 1), there is gradual improvement in symptoms.

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC
• MDR Report Key: 8306294
• MDR Text Key: 135679206
• Report Number: MW5083697
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 57