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

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

Patient Problems Irritation (1941); Swelling (2091); Burning Sensation (2146)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

The patients weight is not provided as it is not taken at the time of the appointment.The patient's race and ethnicity were not provided when asked.Not applicable to this device with the exception of the lot 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 reaction while wearing the comfort hard-soft device.The symptoms were as follows: swelling of lips, tongue, and mouth.The patient also noted a "hard time swallowing, burning, and tingling sensation." the device was delivered to the patient on 12-16-2019.Instructions on how to care and store the device was provided to the patient.On (b)(6) 2019, the patient returned for an adjustment.There was no complaint of any reaction at that time.The patient purchased a tooth whitening product.The patient returned on (b)(6) 2019 with complaints of "swelling of lips, tongue, and mouth." the patient also noted a "hard time swallowing, burning, and tingling sensation." the patient had another appointment for cleaning on (b)(6) 2019.No new complaints noted.It is unclear if the patient continued to use the device.The patient had allergy testing on (b)(6) 2019 and the results provided no allergies with the exception of doxycycline, iodine and shellfish.

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 (see attached email) lot# e-pro4.0-11308 (erkoloc-pro) was manufactured from (b)(6) 2019 and was assigned with 3 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.According to the record, patient still keeps the device.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 the reactions could be caused by mouthwash, toothpaste, or soaking material.However, it was unknown the patient was instructed to maintain or clean the device.However, the customer did not provide the information regarding how patient handled and maintained the device.Patient provided her results from allergic testing.Review of material sds confirmed the device contained no substance that can be potentially allergic to patient.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
• Type of Device: THERMOFORM
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9598520
• MDR Text Key: 177579168
• Report Number: 3011649314-2019-00810
• 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: 06/03/2020

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: 12/27/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR