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

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Swelling/ Edema (4577)

Event Date 02/16/2023

Event Type  Injury  

Event Description

The patient reported symptoms of swollen lips, mouth, and tongue.The patient required the following medical intervention: visited the emergency room on (b)(6) 2023, called to 111 on (b)(6) 2023 and also visited a physician on (b)(6) 2023.The patient was prescribed with the following medication: adrenaline prescribed from emergency room on (b)(6) 2023 and antihistamine prescribed by the gp on (b)(6) 2023.The patient reported discontinuing the use of the aligners on (b)(6) 2023 and is currently asymptomatic.

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "warnings - in rare instances, some patients may be allergic to the plastic aligner material".The potential root cause is unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign aligners caused or contributed to the reported symptoms.This event is being filed as an mdr as the patient reported the prescription medication, adrenaline, and an invisalign product was being used.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer (Section G): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: harper shore ; 3030 slater road; morrisville, NC 27560 ; 6159754942
• MDR Report Key: 16548082
• MDR Text Key: 311345627
• Report Number: 2953749-2023-00947
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0139312360(13)230113(91)1896533203N
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K220287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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: 9000
• Device Lot Number: 139312360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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: 46 YR
• Patient Sex: Female