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

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

Patient Problems Inflammation (1932); Itching Sensation (1943); Reaction (2414); Numbness (2415)

Event Date 08/06/2020

Event Type  Injury  

Event Description

The invisalginers were put in on (b)(6) of 2020.My problems began with the 6th set of aligners.I saw a doctor at urgent care for a diagnosis on (b)(6) 2020.After the ointment was prescribed and i tried it for about a week, i had my dermatologist look at my lips and she confirmed that it looked like a severe reaction to the plastic in the aligner trays.She said to continue with the steroid ointment for my lips.I also talked with the urgent care doctor and she prescribed 4 days of a steroid pill to try to knock it out of my system.I had a severe allergic reaction to the plastic used in my invisalign braces, which caused inflammation in my body and my lips.I got dry, chapped lips and sores on my lips, as well as a feeling if itchiness and numbness, that required a visit to urgent care and then to my dermatologist to diagnose and treat.I have since had them taken out.This problem has now been going on for a few weeks, and i was told it may take another couple of weeks to completely go away.I have been prescribed oral prednisone ointment to apply to my lips and now an oral pill to take for 4 days to try to knock it out of my system.Fda safety report id# (b)(4).

• Brand Name: INVISALIGN BRACES
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 10472128
• MDR Text Key: 205339953
• Report Number: MW5096336
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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): Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 59