MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. COMFORT HARD SOFT SPLINT; THERMOFORM MOUTHGUARD

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

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.This information was not provided when asked.The exception of serial number as the device is manufactured by prescription.The device is manufactured by prescription and not implantable.

Event Description

It was reported that the patient had a reaction to the comfort hard soft splint.The device was first used (b)(6) 2018.The patient could not provide the exact day that the reaction occurred.The patient experienced a sore lip.The date of the reaction is unknown, but it cleared up about a day or two.The patient did not require any treatment for the issue.The patient has allergies to dust mites and pollen.The patient notes that she did not seek the advice of allergist.There are no medical or dental history prior to the delivery of the device.The patient current status, "not wearing a bite guard at this time." with regard to the device: th device was rinsed with water prior to the delivery of the device.The patient cleaned it toothpaste and a toothbrush.

Manufacturer Narrative

The device has not been returned.However, the non-visual device evaluation has been completed and the results are as follows: dhr results: the dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Supplier (erkodent) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Lot# e-pro 3.0-11217 (erkoloc-pro) was manufactured from january 18, 2018 and was assigned an expiration of january 2023.Stock product reviewed results: no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results: customer stated the device was available to be returned but has not been received to date.However, the non-visual device investigation has been completed.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu 9091 rev 3.0 (comfort h/s bite splint instruction for use) states to use only clear, cool water to wash the device.Ifu provides warning "do not clean or soak in mouthwash; do not use denture cleanser, hot water, alcohol, hydrogen peroxide; do not place in direct sunlight".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.Supplier erkodent reviewed the incident details and determined the patient symptoms were unclear and an allergic reaction could not be ruled out.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device (haley) following iso 10993 (biological evaluation of medical devices) and the device was evaluated for potential cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The haley test article was thermoformed with layers of erkodent material (erkoloc-pro and erkodur).The test results were listed below and summarized in biocompatibility report for haley sleep device (rpt 9733 rev 1.0) · for cytotoxicity testing, the test article extract showed no evidence of causing cell lysis or toxicity.· for skin irritation, there was no erythema and no edema observed on the skin of the animals treated with the test article.· for sensitization testing, the test article extracts showed no evidence of causing delayed dermal contact sensitization.· the test article showed nonirritant to the oral mucosa as compared to the control article.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: COMFORT HARD SOFT SPLINT
• Type of Device: THERMOFORM MOUTHGUARD
• 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: 12553930
• MDR Text Key: 274322647
• Report Number: 3011649314-2021-00331
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Race: White