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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Insufficient Information (4580)

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.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 patient experienced a stomach-ache.It is unknown when the reaction occurred, but it stopped 2 days after the discontinuation.

Manufacturer Narrative

The device has not been returned.However, the non-visual device investigation 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 3.0-11600 (erkoloc-pro) was manufactured from march 29, 2021 and was assigned an expiration of march 2024.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 provider of record has retired and the office is unable to get the requested information form the patient.However, the non-visual device investigation has been completed.Root cause a root cause for this complaint cannot be explicitly determined.Ifu 9091 rev 4.0 (comfort h/s bite splint instruction for use) states "brush and floss your teeth before use.Rinse mouth well with clean water before inserting the device.If patient uses mouthwash, all traces of mouthwash should be removed by thoroughly rinsing out mouth with water.Rinse bite splint well with clean, cool water before and after use.Clean bite splint with clean, cool water only and let air dry." 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 that it is rather inappropriate to infer the splint directly, unless the patient had an extreme saliva formation.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device 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 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 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 UPPER
• 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: 12512407
• MDR Text Key: 272898547
• Report Number: 3011649314-2021-00329
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121365
• 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: 03/22/2022

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: 08/31/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 02/23/2022
• Supplement Dates FDA Received: 03/23/2022
• 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 Sex: Male