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

Model Number	INVISALIGN SYSTEM - COMPREHENSIVE
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Nausea (1970); Angioedema (4536); Swelling/ Edema (4577)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "warning - in rare instances, some patient may be allergic to the plastic aligner material, discontinue use and consult a health care professional immediately." the potential root cause is unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused the reported symptom.This event is being filed as an mdr as the patient presented hereditary angioedema and the invisalign product was being used.
Event or Problem Description
The patient reported symptoms of blush, nausea, difficulty breathing and swollen eye.The patient did not report requiring any medical intervention to alleviate the reported symptoms.The patient reported being prescribed eye drops to alleviate the reported symptoms.The treating doctor reported that the patient presented evidence of hereditary angioedema (hae).The treatment was discontinued on (b)(6) 2022 and the patient is currently getting better.

• Brand Name: INVISALIGN SYSTEM
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: aaheli poddar ; 2820 orchard parkway; san jose, CA 95134 ; 4084701340
• MDR Report Key: 15108624
• Report Number: 2953749-2022-02192
• Device Sequence Number: 5255742
• Product Code: NXC
• UDI-Device Identifier: 00816063020264
• UDI-Public: (01)00816063020264(10)0117813004(13)220509(91)1693085901N
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM - COMPREHENSIVE
• Device Catalogue Number: 8812
• Device Lot Number: 210019230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Male