MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. VIVERA RETAINER; MAINTAINER, SPACE PREFORMED

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Irritation (1941)

Event Date 04/05/2018

Event Type  Injury  

Event Description

It has happened every time i use my vivera tray from invisalign.My tongue and throat feel irritated and i have a bad cough for a few days.I kept associating it with my seasonal allergies but have ruled that out as i always feel fine before putting the trays in.

• Brand Name: VIVERA RETAINER
• Type of Device: MAINTAINER, SPACE PREFORMED
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 7411264
• MDR Text Key: 105212953
• Report Number: MW5076381
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 32 YR
• Patient Weight: 54