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 01/07/2021

Event Type  Injury  

Manufacturer Narrative

The device has been returned.Once the investigation is complete a supplemental report will be submitted.The patients weight is not provided as it is not taken at the time of the appointment.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 and is not implantable.

Event Description

It was reported that the patient had a reaction to the comfort hard soft splint device.The patient has no medical history or allergies noted.However, there is suspected tmj (temporomandibular joint).The patient first used the device on (b)(6) 2021 and reports that on that night they experienced irritation at the top of her tongue.The symptoms lasted for one month.There was no medical treatment required.However, the patient went to an allergist, but the testing could not be done due the limitations at the facility.The allergist suggest a different device mad from different material.The patient has switched to the clearsplint.The patient has had no reaction with the clearsplint to date.With regards to the device: the device was cleaned with warm water prior to the delivery of the device.

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.Lot# e-pro4.0-11427 (erkoloc-pro) was manufactured from 4/15/20 and was assigned with 3 years expiration.Complaint investigator reviewed the returned device.An upper tray was returned with am original case.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.The results were summarized below: roughness - the edge was smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device was transparent and no discoloration was observed.General cleanliness - the returned device appeared to be clean, free of debris or foreign particles.Supplier (b)(4) reviewed the incident details and determined it as rather an irritation at the tip of the tongue due to rubbing the material at night.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.Supplier (b)(4) reviewed the incident details and determined it as rather an irritation at the tip of the tongue due to rubbing the material at night.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: 11938176
• MDR Text Key: 254434608
• Report Number: 3011649314-2021-00198
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Race: White