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

Patient Problem Swollen Lymph Nodes/Glands (4432)

Event Date 12/23/2023

Event Type  Injury  

Event Description

I received invisalign tooth aligners from my dentist.I am a 62 y/o white male.After 1 month of use i woke up one morning with a right neck lymph node very badly swollen and the whole right side of my neck and face very sore.For three days these symptoms persisted until i thought to remove the invisalign braces.Within 72 hours of discontinuing invisalign, my symptoms were much better.Within 96 hours they were gone entirely.I had no other symptoms or illnesses.I have never had symptoms like that before or since.This complaint was prompted by my just seeing an ad for invisalign aimed at teenagers.I am not technical and have no scientific training, but it cannot be smart to put plastic on something as vascular as your gums for a year.I will never let anyone i love wear these things.

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY DE COSTA RICA LA LIMA CENTER
• MDR Report Key: 18641805
• MDR Text Key: 334676193
• Report Number: MW5151050
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: 81 MG ASPIRIN. ; MULTIVITAMIN.
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White