MAUDE Adverse Event Report: ALIGN TECHNOLOGY DE COSTA RICA LA LIMA CENTER INVISALIGN; ALIGNER, SEQUENTIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Rash (2033); Ulcer (2274); Arthralgia (2355); Cognitive Changes (2551); Swelling/ Edema (4577)

Event Date 10/04/2022

Event Type  Injury  

Event Description

I began invisalign on (b)(6) 2022.They give you four trays at a time before you are seen by your dentist for the next batch of trays.During the first batch of trays.I've started to experience headaches, fatigue, mouth sores, and rashes.All of which are unusual for me, but did not connect it at the time.My second batch of trays my headaches became worse, and i started to experience joint pain, and my fatigue was becoming worse, and brain fog.I was also experiencing mouth ulcers, but again did not connect it to invisalign - on my third batch of trays my fatigue was overwhelming and rashes, began popping up all over my body.I had severe brain fog along with migraines.I also had intermittent tongue, swelling, and mouth ulcers.On my fourth batch i only used the first tray, and my lips started to swell, along with mouth, and eyes.When the swelling became so bad i realize that the issues i have been experiencing were directly from the invisalign.I immediately stopped them two days ago.The doctor has prescribed prednisone and zyrtec.I am currently waiting on all of my bloodwork to come back and will follow up.Although my blood work was not testing for the specifics in the invisalign product.I will have to go back and re-test for the specific ingredient in the plastic which invisalign will not disclose.Fda safety report id# (b)(4).

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY DE COSTA RICA LA LIMA CENTER
• MDR Report Key: 15595563
• MDR Text Key: 301744578
• Report Number: MW5112575
• 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: 10/07/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADDERALL; B COMPLEX ; DIM; MELOXICAM ; VITAMIN A; VITAMIN C; VITAMIN D; VITAMIN F
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic