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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Post Traumatic Wound Infection (2447)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided by the patient and internal investigation conducted by access dental lab, there is no conclusive evidence that supports or opposes the fact that the aligners caused, contributed, or would likely cause or contribute to the reported event.This event is being filed as an mdr since the patient reported symptoms or physiological conditions related to an infection.

Event Description

The customer reported that she sustained cuts to her mouth, leading to an infection while wearing aligners.The customer stated that she received medical care at a hospital as a result.It is unknown if aligner treatment was discontinued.

• Brand Name: SMILEDIRECTCLUB ALIGNER SYSTEM
• Type of Device: SEQUENTIAL ALIGNER
• Manufacturer (Section D): ACCESS DENTAL LAB; 1530 antioch pike; antioch TN 37013
• Manufacturer Contact: bernie silvers ; 1530 antioch pike; antioch, TN 37013 ; 5127642249
• MDR Report Key: 12657828
• MDR Text Key: 277175462
• Report Number: 3014658399-2021-00106
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00850007728007
• UDI-Public: (01)00850007728007
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2021
• 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): Hospitalization; Other
• Patient Age: 30 YR