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

Model Number	VIVERA RETAINER
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Burning Sensation (2146); Swelling/ Edema (4577)
Date of Event	02/04/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2953749-2023-00582
• Device Sequence Number: 6318417
• Product Code: DYT
• UDI-Device Identifier: 00816063020110
• UDI-Public: (01)00816063020110(10)0139026120(13)230110(91)1714794701R
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male