MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. ASTRON CLEAR SPLINT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Burning Sensation (2146)

Event Date 06/23/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.

Event Description

It was reported that the patient experienced a reaction to the soft night guard.The type of allergic reaction noted was a burning sensation to the tongue.The reaction started on 6-23 and wore it half way through the night into 6-24.The duration of the event lasted 6 days and still having discomfort.The provider advised to stop usage of appliance.The office was advised patient is "having a chemical burn" and seen by urgent care.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: dhr results: dhr not applicable.Device is fabricated per physician's prescription only.Stock product reviewed results : no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results: the device case was returned but no splint was inside.There have been attempts to establish communication with the provider but there has been no response.However, the non-visual device investigation has been completed.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu 012579 rev 1.0 (clearsplint instruction for use) states "brush and floss before using clearsplint.After use, rinse the bite splint with water and store dry.Clean bite splint with soap and warm water only." ifu 012579 provides warning "do not clean or soak in mouthwash; do not use denture cleanser; do not place do not place the clearsplint in hot or boiling water or expose to excessive heat (such as direct sunlight).This may distort the appliance; do not use alcohol or hydrogen peroxide." it is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.However, the customer did not provide the information regarding how the patient handled and maintained the device.Per rpt 012574 rev.1.0 (clearsplint biocompatibility report), the device materials have been found to be biocompatible through the testing.There was no cytotoxic, sensitization, skin irritation, or oral mucosal irritation found in any of the test articles.

• Brand Name: ASTRON CLEAR SPLINT
• Type of Device: ASTRON CLEAR SPLINT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson dr.; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: herbert crane ; 2144 michelson drive; irvine, CA 92612 ; 9495021907
• MDR Report Key: 12224591
• MDR Text Key: 263392321
• Report Number: 3011649314-2021-00251
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female