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 Hypersensitivity/Allergic reaction (1907)

Event Date 03/08/2024

Event Type  Injury  

Event Description

The treating doctor reported that the patient had reported symptoms of an allergic reaction: swollen gums, tingling, tenderness, redness, and itchiness in the tongue, lymph nodes, and cheeks.The patient reported that all of the reported symptoms were in the patient's oral cavity and did not extend to any other body part, and that the reaction started with minor symptoms, but worsened during the week, ending with the hospital visit (er) on (b)(6) 2024.The patient reported requiring the following in relation to the reported symptoms: a visit to the emergency room and a 2-day hospitalization, beginning on (b)(6) 2024.The patient reported being seen by an oral surgeon and a primary care physician.The patient reported requiring iv steroids to alleviate the reported symptoms.The patient reported discontinuing the use of the aligners (unspecified date, but about a week after starting treatment) and is currently getting better.

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "warnings - in rare instances, some patients may be allergic to the aligner material (e.G., plastic, coating material) including aligners with occlusal blocks material".The treating doctor shared that the potential root cause of this event could have been an allergy to the aligners (in agreement with the oral surgeon and pcp diagnosis of allergic reaction to the aligners), and shared that the patient is still interested in continuing with treatment.This event is being filed as an mdr as the patient reported requiring hospitalization, and the invisalign system aligners were 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 ; 4084701343
• MDR Report Key: 18946521
• MDR Text Key: 338184912
• Report Number: 2953749-2024-00703
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0175298574(13)240207(91)2317877901N
• 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: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 175298574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female