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

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

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Anxiety (2328); Neck Pain (2433); Palpitations (2467)

Event Type  Injury  

Event Description

After a few months into wearing my invisalign retainers, my health started to progressively deteriorate.I had been very healthy my whole life until i started my invisalign.At one point i was needing to go to the doctor and or hospital, so often that my job designated me my own personal nurse to help me with this mystery health issue.I've been to the er because of tight chest, elevated resting heart rate, shortness of breath and chest pain, the er couldn't find anything wrong with me.I've had my throat dilated 2 times and they said i was perfectly healthy.I've followed up at a specialist heart doctor which he said i was perfectly healthy.I've worked with 2nd md to guide with what possibly was causing these symptoms.They were unable to pin point the problem.I've had many symptoms including rapid heart beat, anxiety, upper back and neck pain, gastrointestinal issues, difficulty swallowing solid foods.I was once an athlete and now i haven't been able to go to the gym in months because of overall weakness and fatigue.Fda safety report id# (b)(4).

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 10465493
• MDR Text Key: 204978376
• Report Number: MW5096318
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 34 YR
• Patient Weight: 57