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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Nausea (1970)

Event Date 04/03/2019

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.

Event Description

Customer called in thinking she could be having an allergic reaction.After she puts the aligners in for about 1-3 hrs she feels nauseous.

• Brand Name: SMILEDIRECTCLUB ALIGNER SYSTEM
• Type of Device: SEQUENTIAL ALIGNER
• Manufacturer (Section D): ACCESS DENTAL LAB; antioch TN 37013
• Manufacturer (Section G): ACCESS DENTAL LAB; 1530 access dental lab; antioch TN 37013
• Manufacturer Contact: bernie silvers ; 1530 antioch pike; antioch, TN 37013
• MDR Report Key: 10762315
• MDR Text Key: 213865974
• Report Number: 3014658399-2019-00007
• 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 Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2018
• 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