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

Model Number CCA7B41A62056B

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

Patient Problem Insufficient Information (4580)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

Additional contact was made with the patient to collect additional information.According to the patient history, they indicated they did not have any pre-existing medical conditions prior to starting treatment.The patient indicated that after 36 hours the symptoms started subsiding and that they were improving.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 similar to that of an allergic reaction.

Event Description

Patient reported swelling in the throat and cuts in his mouth.The patient required medical intervention to alleviate the reported symptoms and was prescribed pain medication to alleviate the reported symptoms.The patient discontinued further aligner treatment.

• Brand Name: SMILEDIRECT CLUB ALIGNER SYSTEM
• Type of Device: SEQUENTIALALIGNER
• Manufacturer (Section D): ACCESS DENTAL LAB; 1530 antioch pike; antioch TN 37103
• Manufacturer Contact: lacey chessor ; 1530 antioch pike; antioch, TN 37013 ; 6158369201
• MDR Report Key: 11036134
• MDR Text Key: 222285498
• Report Number: 3014658399-2020-00011
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Public: (01)0085000772800-7
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CCA7B41A62056B
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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: 26 YR