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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

Several attempts were made to contact the patient to collect additional information, all attempts were unsuccessful.Based on the information provided by the patient, 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 similar to that of an allergic reaction.

Event Description

Patient reported symptoms of shortness of breath, swelling in the mouth and gums with bleeding and lethargy.It is unknown if the patient required medical intervention to alleviate the reported symptoms or if the patient took or was prescribed medication to alleviate the reported symptoms.The patient discontinued further aligner treatment.

• 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: 10953451
• MDR Text Key: 219870355
• Report Number: 3014658399-2020-00010
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• 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
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2020
• 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: 54 YR