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

Lot Number 1107022353

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

Patient Problems Rash (2033); Reaction (2414)

Event Date 07/11/2020

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.Device info is not applicable with the exception of lot number as the device is manufactured by prescription.Implant and explant date is not applicable as the device is manufactured by prescription not implantable.

Event Description

It was reported that the patient developed hives over her neck, under arms, face and rashes around the mouth shortly after delivery on (b)(6) 2020.The patient has a history of hypertension, restless leg syndrome (rls) and gerd.Current medications include: metoprolol 25mg, pramipexole and prilosec.The patient has an allergy to sulfa drugs.The patient received the device on (b)(6) 2020 and experienced the reaction on (b)(6) 2020.However, the patient continued to use the device another 10 days.She discontinued the device on (b)(6) 2020 and the reaction resolved in 2 days.The patient called the provider and requested treatment.The patient was given an unknown pain medication and triamcinolone.The patient current stats is noted as "good." with regard to the device: the device was rinsed with warm water prior to delivery.The patient was instructed to clean the device with warm water.

Manufacturer Narrative

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 (b)(4) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Lot# e-pro4.0-11263 (erkoloc-pro) was manufactured from 11/23/18 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: complaint investigator reviewed the returned device with an original case.The results were summarized below: roughness - the edge was smooth.Crack - no major cracks were found.Delamination - layers were intact and did not separated.Discoloration - no discoloration was observed.General cleanliness - the returned device was not clean and debris can be observed.Case was returned in a good condition with label.The returned device was visually inspected and no defect and abnormality was observed.There was no evidence found to indicate that the reported issue was caused by the device itself.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 reported patient was instructed to maintain or clean the device with warm water.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.

• 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
• MDR Report Key: 10375883
• MDR Text Key: 202003357
• Report Number: 3011649314-2020-00597
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1107022353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 93