MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. COMFORT 3D BITE 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 there is more information provided, a supplemental report will be submitted.

Event Description

It was reported that the patient experienced redness and cracks around the gingiva.The device was delivered 3-3-22 with the reaction occurring 4-5 days after (exact date unknown).The reaction lasted for 10 days (exact date unknown).The patient was instructed to use a "steroid",(tpye unknown) but declined.The patients current status is noted as "feels fine."there is no medical or dental history noted.

Manufacturer Narrative

The device was returned, the 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# lk2153 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.Comfort3d bite splint was returned in the original case.The results were summarized: roughness - the flange was smooth; internal/external surfaces were smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device did not show any signs of discoloration.General cleanliness - 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 a 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.Per the reported information, the device was cleaned with cavi-spray by the provider.Additionally, the patient used anti-bacterial dish soap and soft toothbrush.(b)(4) (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 BITE 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: 14469992
• MDR Text Key: 292375458
• Report Number: 3011649314-2022-00288
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female