MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM; MAINTAINER, SPACE PREFORMED, ORTHODONTIC

Model Number VIVERA RETAINERS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Fatigue (1849); Inflammation (1932); Burning Sensation (2146)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes that fact that the vivera retainers caused or contributed to the patients symptoms.This event is being filed as an mdr as the patient reported the symptom of chest pain while an align product was being used.

Event Description

The patient reported the symptoms of coughing, difficulty breathing, chest pain, dermatitis on the chin, fatigue, salivary gland inflammation, and a burning sensation on the tongue and lips.The patient reported having visited a pulmonary specialist, urgent care, and a primary care physician due to the reported symptoms.The patient did not report taking or being prescribed any medication to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2019.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: ryan hoffmeister ; 2820 orchard parkway; san jose, CA 95134 ; 4087891588
• MDR Report Key: 9241495
• MDR Text Key: 163931617
• Report Number: 2953749-2019-02761
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIVERA RETAINERS
• Device Catalogue Number: 8580
• Device Lot Number: 30342305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR