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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Hair Loss (1877); Inflammation (1932); Pain (1994); Rash (2033); Swelling (2091); Swollen Lymph Nodes (2093); Ulceration (2116); Weakness (2145); Dizziness (2194); Ulcer (2274); Depression (2361); Sensitivity of Teeth (2427); Skin Inflammation (2443); Blood Loss (2597); Weight Changes (2607)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Caller called to report that since she started wearing invisalign she has had mouth sores, mouth ulcers, canker sores at the roof of her mouth with severe bleeding.She reports that her mouth has bleed so, much that she has to use a paper towel to absorb the bleeding."my invisalign bloody nightmare." she also, reports that she has had dermatitis, red patches around lips, chin, and cheeks.She has felt weakness, dizziness, and fatigue.Has had severe pain while brushing her teeth, hears clicking noise on both sides of her jaw, has inflammation in and around her face with swollen nodules.She has had hair loss, itching, depression, weight loss due to having pain while eating.Reporter states that she has had to use nystatin, and magic mouthwash for treatment.She has spoken to her dentist several times about this problem; recently while speaking to two of the dentist one of them briefly mentioned that this could be an invisalign reaction.While, the other dentist dismisses the idea that the reporter was having a reaction due to the invisialgn.Shortly, after she had this conversation with the dentists.Attorneys for the dental practice called and offered her (b)(6) and asked the reporter to never come back if she accepts this payout.The reporter states that she refused to accept the payment.She reports that she has had to have a biopsy due to the mouth ulcers and may develop cancer.

Event Description

Additional information received from reporter on 4/3/2020 for mw5091291.Reporter experienced ambulation difficulties, she also experiences neurological issues, aphthous ulcers, pemphigus edema, weight gain (20lbs) and lethargy."feels she is being killed from inside out".Awaiting reports and further testing which have been delayed due to the corona pandemic.

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9376647
• MDR Text Key: 168216909
• Report Number: MW5091291
• 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,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 50