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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 07/25/2020

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 smiledirectclub aligner system was being used.

Event Description

The patient reported symptoms of an allergic reaction in the form of itchy throat, sore gums and throat swelling.The patient removed the aligners and the symptoms subsided.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: lacey chessor ; 1530 antioch pike; antioch, TN 37013 ; 6158369201
• MDR Report Key: 10762396
• MDR Text Key: 213866445
• Report Number: 3014658399-2020-00007
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Public: (01)0085000772800-7
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/31/2020

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
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 07/25/2020
• Initial Date FDA Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• Is the Device Single Use?: Yes
• 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: 48 YR