MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC INVISALIGN SYSTEM; MAINTAINER, SPACE PREFORMED, ORTHODONTIC

Model Number VIVERA RETAINER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Sore Throat (2396); Angioedema (4536)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes the fact that the vivera retainers caused or contributed to the reported symptom.This event is being filed as an mdr as the patient reported angioedema while an invisalign product was being used.

Event Description

The patient reported the symptoms of angioedema, swollen tongue and throat, and sore throat.The patient did not report requiring any medical intervention due to the reported symptoms.The patient did not report taking or being prescribed any 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: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• 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: nestor vazquez ; 2820 orchard parkway; san jose, CA 95134 ; 4084701480
• MDR Report Key: 10535706
• MDR Text Key: 207140661
• Report Number: 2953749-2020-02428
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIVERA RETAINER
• Device Catalogue Number: 8580
• Device Lot Number: 36247816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2020
• 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: 57 YR