MAUDE Adverse Event Report: ACCESS DENTAL LAB SMILEDIRECT CLUB ALIGNER SYSTEM; SEQUENTIAL ALIGNER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Sore Throat (2396); Reaction (2414)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes the fact that the aligners caused or contributed to the patient's symptoms.This event is being filed as a mdr as the patient reported an allergic reaction episode while a (b)(4) aligner system was being used.Although the intial submission was completed within the 30 calendar day reporting timeline, this mdr is being reported outside of the 30 calendar day reporting timeline due to initial incomplete submission resulting in a lack of e-submission ack3 confirmation.

Event Description

The patient reported symptoms of an allergic reaction in the form of tongue/lip burning sensation and face swelling.As a result, the patient discontinued use of the plastic aligners.

• Brand Name: SMILEDIRECT CLUB ALIGNER SYSTEM
• Type of Device: SEQUENTIAL ALIGNER
• Manufacturer (Section D): ACCESS DENTAL LAB; 1530 antioch pike; antioch TN 37013
• Manufacturer Contact: brent silvers ; 1530 antioch pike; antioch, TN 37013 ; 6787678946
• MDR Report Key: 10788154
• MDR Text Key: 214653664
• Report Number: 3014658399-2019-00055
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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: 55 YR