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 Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Swelling/ Edema (4577)

Event Date 10/20/2023

Event Type  Injury  

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 treating doctor shared that the potential root cause of this event could be an allergic reaction.Based on the available information, the patient reported requiring iv benadryl (indicative of an acute, life-threatening event) and spent one night in the hospital (initial hospitalization) and the invisalign product was being used, and therefore, this event is being filed as an mdr.

Event Description

The patient reported symptoms of itching gums, swelling, pain, vomiting, and shortness of breath.The patient shared that the patient tried rubbing the tray on the skin (chest area) and it had a reaction as well.The patient reported requiring a visit to the er and stayed one night to alleviate the reported symptoms.The patient reported being prescribed the following medication: iv benadryl.The patient reported discontinuing the use of the aligners on (b)(6) 2023 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 ; 4084701343
• MDR Report Key: 18051906
• MDR Text Key: 327127975
• Report Number: 2953749-2023-03205
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0163147074(13)230928(91)2058562001N
• 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: 11/01/2023

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: 163147074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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; Life Threatening
• Patient Age: 39 YR
• Patient Sex: Female