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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/02/2021

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 patients weight is not provided as it is not taken at the time of the appointment.The patients race/ethnicity was not provided when asked.Is not applicable with the exception of serial number as the device is manufactured by prescription.Is not applicable as the device is manufactured by prescription not implantable.This is the second of two implant complaints, see manufacturer report for the remaining complaint : 3011649314-2021-00227.

Event Description

It was reported that the patient had a reaction to the comfort hard-soft splint.The device was first used by the patient on (b)(6) 2021 and developed a reaction to the device.The patient experienced an "intense tingling sensation of the lips and tongue as well as soreness of the tongue." there were "erythematous mucosa bilaterally in maxillary and buccal vestibules."the patient continued the device on (b)(6) 2021.However, the patient tried to use the device once more on (b)(6) 2021 and the symptoms returned the morning (b)(6) 2021 and once again the device was discontinued.The reaction lasted 3-5 days after the discontinuation the device.The patient was prescribed lidex gel 0.05%, but patient decided not to use it.The patient has no medical history noted, but has an allergy to neomycin.The patient has had allergy test done, but it was to detect food allergies.With regard to the device: the provider notes cleaning it with cavacide then cleansed it thoroughly with water prior to the delivery to the patient.The patient was instructed to "clean with mild soap/detergent and running water.".

Manufacturer Narrative

The 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 ((b)(4)) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Additionally, (b)(4) reported no further complaints for this material lot.Lot# e-pro 4.0-11465 (erkoloc-pro) was manufactured from november 3, 2020 and was assigned an expiration of november 2023.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 reported the device would be returned but to date has not been received.However, the non-visual device investigation has been completed.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".Per the reported information, the provider cleaned the device with cavacide and then thoroughly with water.Additionally, the patient was to clean with a mild soap/detergent and running water.It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.Supplier (b)(4) reviewed the incident details and determined an allergic reaction could not be ruled out.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 (b)(4) 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 MOUTHGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2301dupont drive; suite 250; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2301 dupont drive; suite 250; irvine CA 92612
• Manufacturer Contact: herbert schoenhoefer ; 2301 dupont drive; suite 250; irvine, CA 92612 ; 9494402532
• MDR Report Key: 12000230
• MDR Text Key: 257459691
• Report Number: 3011649314-2021-00244
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• 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
• Date Manufacturer Received: 12/16/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female