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 Sore Throat (2396)

Event Type  Injury  

Manufacturer Narrative

The patients weight is not provided as it is not taken at the time of the appointment.Date of event is unknown when asked this section is not applicable for this device.With the exception of the serial number.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 had a possible allergic reaction to the night guard.The provider notes that the patient felt the device is causing a sore throat.The patient has allergies to latex and metals, but it is not known which metals the patient is allergic to.The provider also notes the patient has food allergies, but was not specific when asked.It is unclear when the reaction to the device occurred, only that it happened shortly after use.The patient discontinued use of the device when the reaction occurred.The patient was provided care and storage instructions when the device was delivered.

Manufacturer Narrative

The physical 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.The device was fabricated per physician's prescription only.Supplier (erkodent) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality 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.The 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.The ifu also provides this 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, patient was instructed to clean the device with anti-bacterial soap and warm water per updated information.The patient was reported to be allergic to latex and metal.Complaint investigator reviewed the prescription and confirmed no latex was used when fabricating this reported device.Review of sds also confirmed the material contains no latex or any metal.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device (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 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 CA 92612
• MDR Report Key: 9676041
• MDR Text Key: 177992450
• Report Number: 3011649314-2020-00445
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• 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
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR