MAUDE Adverse Event Report: ALIGN TECHNOLOGY INC. INVISALIGN; ALIGNER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dysphagia/ Odynophagia (1815); Swelling (2091); Burning Sensation (2146); Tingling (2171)

Event Date 07/23/2018

Event Type  Injury  

Event Description

First time of invisalign.Within hours of insertion of my 1st tray by my orthodontist, i had a bad adverse reaction.Swollen, burning and tingling of throat, tongue, soft palate and lips.Felt like throat was closing.Difficulty swallowing.

• Brand Name: INVISALIGN
• Type of Device: ALIGNER
• Manufacturer (Section D): ALIGN TECHNOLOGY INC.
• MDR Report Key: 7731208
• MDR Text Key: 115598561
• Report Number: MW5078682
• Device Sequence Number: 1
• Product Code: ECQ
• 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: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 48 YR
• Patient Weight: 66