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 Pain (1994); Swelling/ Edema (4577)

Event Date 11/29/2022

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 have been an allergic reaction.This event is being filed as an mdr as the patient was prescribed an epipen and the invisalign product was being used.

Event Description

The patient reported symptoms of swollen throat and mouth, and pain in the oral cavity.The patient reported requiring visiting her primary care physician to alleviate the reported symptoms.The patient reported being prescribed epipen and prednisone 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: 15973816
• MDR Text Key: 305412578
• Report Number: 2953749-2022-04223
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0134320485(13)221115(91)1712868401N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 134320485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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: 28 YR
• Patient Sex: Male