MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. COMFORT 3D 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 been returned.Once the investigation is complete a supplemental report will be submitted.This is the first of two complaints for the same patient.See manufacturer report for the remaining complaint : 3011649314-2021-00352.

Event Description

It was reported that the patient had a reaction to comfort bite splint.The patient's reaction consisted of swelling, itching and soreness of the gums and lips.It is unclear when the patient first used the device.However, the provider notes that the reaction started on (b)(6) 2021, then discontinued the device for a few nights.The patient attempted to use the device again on (b)(6) 2021 and had the same results.The patient has a known allergy to gluten, aleve, dicyclomine, ibuprofen and vicodin.The patient also has a history of celiac disease and is lactose intolerance.

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 for case #(b)(4) and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.The receiving router for lot# lb2925 indicated printer resin from keystone industries (supplier) passed inspection and met the specification.C of a (certificate of analysis) was also provided and confirmed the material was qualified for release.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.An upper tray was returned in the original case.The results were summarized, and the pictures were attached.Roughness: the edge flange of the device was smooth along with interior/exterior surfaces.However, the occlusal surface at tooth #15 had visible signs of adjustments and traces of contact paper.Crack: no major crack was found.Delamination: layers were intact and did not separate.Discoloration: no discoloration was visible.The device is already colored- purple/transparent hue.General cleanliness: case was returned in a good condition with label.The returned device appeared to be clean, free of debris or foreign particles.The returned device was visually inspected, and no defect or 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 12383 rev 3.0 (comfort3d 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".It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.However, the customer did not provide the information regarding how the patient handled and maintained the device.Per the reported information, the patient has a known allergy to gluten, aleve, dicyclomine, ibuprofen and vicodin.It was also noted that the patient has a history of celiac disease and is lactose intolerance.Rpt 012620 rev.1.0 (comfort3d bite splint verification), confirms that the resin material meets the acceptance criteria for biocompatibility (cytotoxicity, irritation, and sensitization) and mechanical properties (flexural strength, flexural modulus, sorption, solubility, and free monomer extraction).

• Brand Name: COMFORT 3D SPLINT
• Type of Device: THERMOFORM MOUTHGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: herbert crane ; 2144 michelson drive; irvine, CA 92612 ; 9495021907
• MDR Report Key: 12476436
• MDR Text Key: 271701323
• Report Number: 3011649314-2021-00321
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183598
• 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: 11/19/2021

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: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2021
• 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 Sex: Female