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 Problems Fatigue (1849); Fever (1858); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 12/21/2022

Event Type  Injury  

Manufacturer Narrative

The current instructions for use (ifu) contains the following; "warning - in rare instances, some patients may be allergic to the plastic aligner material, discontinue use and consult a health care professional immediately".The treating doctor shared that the potential root cause of this event could have been an allergic reaction.This event is being filed as an mdr as the patient reported the symptoms of elevated heart rate and difficulty breathing and the invisalign product was being used.

Event Description

The patient reported symptoms of elevated heart rate, difficulty breathing, fatigue and drained, fever, swollen face and lips.The patient reported requiring visiting a physician to alleviate the reported symptoms.It is unknown if medications were prescribed to alleviate the reported symptoms.The patient reported discontinuing the use of the aligners on (b)(6) 2022 and is currently getting better.

• 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: 16234906
• MDR Text Key: 308021886
• Report Number: 2953749-2023-00172
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0135563026(13)221129(91)1884009301N
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220287
• 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: 01/24/2023

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: INVISALIGN SYSTEM - COMPREHENSIVE
• Device Catalogue Number: 9000
• Device Lot Number: 135563026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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: 54 YR
• Patient Sex: Female