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

Model Number INVISALIGN SYSTEM - LITE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Anaphylactic Shock (1703); Fatigue (1849); Headache (1880); Itching Sensation (1943); Abdominal Cramps (2543); Swelling/ Edema (4577)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptom.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 anaphylactic shock, itchy eyes, swollen armpits, breathing issues, swollen feeling of the throat, stomach cramps, fatigue (extremely tired), headaches, and their tongue was changing colors.The patient reported calling the emergency number to alleviate the reported symptoms.The patient did not report requiring medical intervention to alleviate the reported symptoms.The patient did not report taking or being prescribed medication to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2020 and the patient is currently asymptomatic.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: SEQUENTIAL ALIGNERS
• 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: 10577199
• MDR Text Key: 208301894
• Report Number: 2953749-2020-02436
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• 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: 34731905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2020
• 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: 47 YR