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 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.Weight: the patients weight is not provided as it is not taken at the time of the appointment.Date of event: this information was not provided when asked.It is not applicable with the exception of serial number as the device is manufactured by prescription.Implant, explant dates is not applicable as the device is manufactured by prescription not implantable.

Event Description

It was reported the patient had a reaction to the comfort splint.The location of the reaction was noted as slight bumps intra orally near pre molar /lip area.The device was delivered on (b)(6) 2021 and the patient first used the device he same night.It is unknown when the reaction occurred.However, the provider notes, "patient feels bumps and it feels like the lips were swelling." on (b)(6) 2021 there were no signs of the reaction, but felt the symptoms.The patient did not require any medical treatment, they just discontinued using the device.The patient has allergies to latex and hazelnuts.The patient did not have allergy testing prior to or after using the device.The patient has a history of diabetes, hypertension, hypercholesterolemia and a surgical history of a joint replacement (site unknown).With regards to the device: the device was cleaned prior to delivery to the patient.The patient was instructed to clean with water and a "brush." the device is available and will be returned.

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.Additionally, erkodent reported no further complaints related to this material lot.Lot# e-pro 4.0-11497 (erkoloc-pro) was manufactured from october 7, 2020 and was assigned an expiration date of october 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: the provider stated the device would be returned but to date has not been returned.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".Per the reported information, the patient has allergies to latex and hazelnuts.The patient did not have allergy testing prior to or after using the device.It was also noted that the patient has a history of diabetes, hypertension, hypercholesterolemia, and a surgical history of a joint replacement (site unknown).Additionally, it was noted the device was cleaned prior to delivery but no mention as to how.It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.Supplier (b)(4) reviewed the incident details and determined the incident is more of a mechanical irritation.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 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: 11914427
• MDR Text Key: 253729709
• Report Number: 3011649314-2021-00205
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• 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: 11/29/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 73 YR
• Patient Sex: Female
• Patient Race: White