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

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Numbness (2415); Swelling/ Edema (4577)

Event Date 03/01/2021

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 puffy lips, swollen face, numbness of the left side, and facial drop on the right side.The patient reported regularly taking probiotics and multivitamins prior to starting the treatment.The patient reported visiting the er, due to the reported symptoms.The patient reported being prescribed epinephrine to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2021 and the patient is currently getting better.

• 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: 11668344
• MDR Text Key: 262413956
• Report Number: 2953749-2021-00834
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM - COMPREHENSIVE
• Device Catalogue Number: 8812
• Device Lot Number: 38102586
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2020
• 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: 34 YR