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

Model Number INVISALIGN SYSTEM - LITE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Anaphylactic Shock (1703); Dyspnea (1816); Erythema (1840); Pain (1994); Burning Sensation (2146); Dizziness (2194)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes that fact that the invisalign system aligners caused or contributed to the patients symptoms.This event is being filed as an mdr as the patient reported an anaphylactic episode while an align product was being used.

Event Description

The patient reported symptoms of moderate anaphylaxis, sever thoracic pain, shortness of breath (dyspnea), dizziness, throat erythema (reddening), burning sensation of the cephalic (head), weird body sensation (unspecified), and aphonia (loss of speech).The patient reported visiting the er two times, and was diagnosed with idiopathic anaphylaxis during the second visit.The patient had a tbd test and a spirometry fvc performed, test results are unknown.The patient was prescribed salbutamol (albuterol), budesonide (steroid) to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2019 and the patient is currently asymptomatic.The treating doctor believes the symptoms are associated with the aligners.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: ryan hoffmeister ; 2820 orchard parkway; san jose, CA 95134 ; 4087891588
• MDR Report Key: 9293719
• MDR Text Key: 166945925
• Report Number: 2953749-2019-02969
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K181739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/06/2019

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 - LITE
• Device Catalogue Number: 8844
• Device Lot Number: 29136485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• 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): Life Threatening
• Patient Age: 40 YR