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

Model Number VIVERA RETAINER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Anaphylactic Shock (1703); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 02/04/2023

Event Type  Injury  

Manufacturer Narrative

The current instructions for use (ifu) contains the following: "warnings - in rare instances, some patients may be allergic to the plastic retainer material.In such cases, discontinue use and consult a health care professional immediately".The treating doctor shared that the potential root cause of this event could have been an allergic reaction.This event is being filed as an mdr as the patient reported an anaphylactic reaction and reported the usage of an epi-pen to allevieate the reported symptoms and the vivera retainers were being used.

Event Description

The patient reported symptoms of swollen lips, burning sensation and anaphylactic episode.The patient reported requiring visiting the emergency room to alleviate the reported symptoms.The patient reported being prescribed prednisone and epi-pen by the emergency room to alleviate the reported symptoms.The patient reported discontinuing the use of the retainers on (b)(6) 2023 and is currently asymptomatic.

• Brand Name: VIVERA RETAINER
• 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: harper shore ; 3030 slater road; morrisville, NC 27560 ; 6159754942
• MDR Report Key: 16358016
• MDR Text Key: 309333372
• Report Number: 2953749-2023-00582
• Device Sequence Number: 1
• Product Code: DYT
• UDI-Device Identifier: 00816063020110
• UDI-Public: (01)00816063020110(10)0139026120(13)230110(91)1714794701R
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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: 8579
• Device Lot Number: 139026120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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: 75 YR
• Patient Sex: Male