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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Sore Throat (2396)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes that fact that the aligners caused or contributed to the patients symptoms.This event is being filed as a mdr as the patient reported an allergic reaction episode while an smiledirectclub aligner system was being used."although the initial 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 an 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 swelling.As a result, the patient discontinued use of the plastic aligners.

• Brand Name: SMILEDIRECTCLUB ALIGNER SYSTEM
• Type of Device: SEQUENTIAL ALIGNER
• Manufacturer (Section D): ACCESS DENTAL LAB; antioch TN
• Manufacturer Contact: bernie silvers ; 1530 antioch pike; antioch, TN 37013
• MDR Report Key: 10762333
• MDR Text Key: 213865743
• Report Number: 3014658399-2019-00026
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2019
• 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