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

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Asthma (1726); Chest Pain (1776); Fatigue (1849)

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 symptoms.This event is being filed as an mdr as the patient reported chest pain while an invisalign product was being used.

Event Description

The patient reported the symptoms of long periods of cough, which end in deep chest pain, shortness of breath, asthma, and fatigue.It is unknown if the patient takes medications regularly or has any allergies and pre-existing conditions.It is unknown if the patient required medical intervention, medications were taken or prescribed, nor if laboratory tests were performed to alleviate the reported symptoms.It is unknown if the patient is still wearing aligners or how the patient is currently doing.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: SEQUENTIAL ALIGNERS
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC; 2820 orchard parkway; san jose, ca
• Manufacturer (Section G): ALIGN TECHNOLOGY, INC; 2820 orchard parkway; san jose, ca
• Manufacturer Contact: nestor vazquez ; 2820 orchard parkway; san jose, ca ; 4701480
• MDR Report Key: 10501568
• MDR Text Key: 205967319
• Report Number: 2953749-2020-02354
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM - COMPREHENSIVE
• Device Catalogue Number: 8820
• Device Lot Number: 34998046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2020
• 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