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 Pain (1994); Swelling (2091)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If/when the device is returned an investigation of the device will be carried out and a supplemental report will be submitted.The patients weight is not provided as it is not taken at the time of the appointment.Not applicable for this device with the exception of the lot number.

Event Description

It was reported that the patient had swelling and pain while wearing comfort hard-soft splint.The patient is allergic to penicillin.The patient was given care instructions at the initial visit.There are no other allergies or sensitivities noted by provider.The patient reported that she only cleaned the device with water.It was also reported that the patient presented with the device almost monthly (after delivery) with complaints of pain and swelling of the lips.The specific dates could not be provided.However, in (b)(6) 2019, the patient returned for general cleaning and informed the hygienist that, "she had a swelling around the lips and pain to the gums after the 2nd or 3rd night of wear." the patient tried to continue to wear it, but was unable to do so after the 3rd day.The patient returned in (b)(6) 2019 with the same complaints.The patient discontinued using the device in december.

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.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 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.Per obtained information, patient was instructed to clean the device with water only.However, the device was prescribed in 2015 and has been 4 years old.There could be other variables involved in patient's allergic reactions.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 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 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.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9588272
• MDR Text Key: 175020368
• Report Number: 3011649314-2019-00809
• 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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/14/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR