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

Model Number INVISALIGN ASSIST

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptom.This event is being filed as an mdr as the patient reported required epinephrine to alleviate the symptoms and an invisalign product was being used.

Event Description

The patient reported symptoms of swollen tongue and gums, and irritation of the lips and mouth.The patient did not report requiring medical intervention to alleviate the reported symptoms.The patient reported using an epipen to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2021 and the patient is currently asymptomatic.The treating doctor shared the potential root cause could have been an allergic reaction.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: SEQUENTIAL ALIGNERS
• 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: 11765460
• MDR Text Key: 248794195
• Report Number: 2953749-2021-01082
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181739
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN ASSIST
• Device Catalogue Number: 8524
• Device Lot Number: 200634999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2021
• 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): Life Threatening
• Patient Age: 42 YR