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

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

Patient Problem Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned.An investigation will be conducted once the sample has been returned and a supplemental report will be submitted.Model number not applicable.Catalog number not applicable.Lot number not applicable.Expiration date not applicable.Udi number not available.

Event Description

It was reported that a patient experienced an allergic reaction after using a comfort hard-soft bite splint (upper).According to the information provided by the doctor, the patient experienced blisters on the lips on unknown date.It is unknown whether or not the patient has any known allergies.

Manufacturer Narrative

The device has not been returned.However, the device investigation has been completed and the results are as follows: dhr results: no dhr was available for review since the device was fabricated per physician's prescription only.Supplier (erkodent) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Lot# e-pro4.0-11298 (erkoloc-pro) was manufactured from 7/16/18 and was assigned with 4 years expiration.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 was not returned for investigation.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu (b)(4) 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.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device (haley) following iso (b)(4) (biological evaluation of medical devices) and the device was evaluated for potential cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The 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 BITE SPLINT
• Type of Device: THERMOFORM MOUTHGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9608529
• MDR Text Key: 176781405
• Report Number: 3011649314-2020-00004
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• PMA/PMN Number: K121365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

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
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention