MAUDE Adverse Event Report: ACCESS DENTAL LAB IIMPRESSION KIT

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 03/02/2021

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 impression kit putty 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 an allergic reaction.

Event Description

The customer reported to smiledirectclub that she was using one of the "jars" of putty to do an impression and developed symptoms of an allergic reaction in the form of swollen throat; she claimed to have called 911 to request for assistance.The customer reported to have visited the er to alleviate the reported symptoms, nevertheless there was no indication of what type of medication was provided to the customer.The customer reported currently feeling asymptomatic.

Manufacturer Narrative

Supplemental report for mdr 3014658399-2021-0002-1, additional manufacturing information provided since it was not available at the time of initial submission.

• Brand Name: IIMPRESSION KIT
• Type of Device: IIMPRESSION KIT
• Manufacturer (Section D): ACCESS DENTAL LAB; 1530 antioch pike; antioch TN 37013
• MDR Report Key: 11606582
• MDR Text Key: 243528036
• Report Number: 3014658399-2021-00002
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• PMA/PMN Number: K092319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: BDTN10350117ZP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR