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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Reaction (2414)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

There is no objective evidence to support the conclusion that either the use of the smiledirectclub aligners nor the smiledirectclub aligner system caused, contributed, or would likely cause or contribute to the reported symptoms.This event is being filed as an mdr since the patient reported symptoms or physiological conditions similar to that of an allergic reaction which in severe or acute cases could potentially progress to anaphylaxis."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

Customer called in regarding a major reaction to the aligners.Experienced a rash on entire body and had a doctor confirm it was from the aligners.

• 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
• MDR Report Key: 10762305
• MDR Text Key: 213864763
• Report Number: 3014658399-2019-00002
• 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: 05/21/2019

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
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2019
• 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