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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/07/2022

Event Type  Injury  

Event Description

It was reported that the patient had a reaction to the comfort hard soft splint that was issued.The patient received the device on (b)(6) 2022 with the reaction occurring within 5 min and could not be worn for more than 15min.The patient complained of difficulty breathing, foul taste in mouth and numbness.The device was discontinued (b)(6) 2022 that evening.After 20min the reaction resolved.The patient tried once again (b)(6) 2022 and experienced the same reaction.Both times the patient used benadryl.The resolution of the second attempt lasted for an hour.The patient contacted the office on (b)(6) 2033 to provide them a report of the reaction.The patient has allergies to latex, coumadin, natural rubbers codeine, metals and aspirin.These result s were from 15years ago.There are no medical conditions noted.With regards to the device: the patient rinsed after its use and used listerine.The device is not available to return.

Manufacturer Narrative

The device has not been returned.If/when there is more information provided, a supplemental report will be submitted.This is the second of two implant complaints, see manufacturer report for the remaining complaint : 3011649314-2022-00463.

Manufacturer Narrative

Capa 2023-006 the device was returned, the investigation has been completed and the results are as follows: dhr results no lot number provided, therefore no dhr review was completed.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results complaint investigator visually inspected the returned device.The returned parts included both upper and lower trays with the original case.Roughness - the flange was smooth; internal/external surfaces were smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - none.General cleanliness - the returned device appeared to be clean, free of debris or foreign particles.The returned device was visually inspected and no defect or abnormality was observed.There was no evidence found to indicate that the reported issue was caused by the device itself.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.Correction - b5 describe event or problem, d1 brand name, d2 common device name, g4 pma/510(k).

Event Description

The device used was an astron clear splint, not a comfort hard soft splint.

• Brand Name: ASTRON CLEAR SPLINT
• Type of Device: ASTRON CLEAR SPLINT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; 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: 15142398
• MDR Text Key: 297038419
• Report Number: 3011649314-2022-00474
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 91 KG