MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. 3D COMFORT 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 had a reaction to the 3d comfort splint that was issued.It is unclear when the patient received the device, when the patient first used the device, or when the reaction occurred or resolved.However, it is noted that the patient went to the emergency room for the reaction and has not been seen by the dental provider.

Manufacturer Narrative

The device has not been returned.However, the non-visual device evaluation has been completed and the results are as follows: dhr results no dhr was reviewed as no lot number was provided.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 has not returned the product or provided an image for review.However, the non-visual device investigation has been completed.Root cause a root cause for this complaint cannot be explicitly determined.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.Ifu 12383 rev 3.0 (comfort3d bite splint) contains the following statement in the warning section: "use only clear, cool water to wash the device.A soft toothbrush may be used.Do not clean or soak in mouthwash.Do not use denture cleanser.Do not use hot water.Do not use alcohol or hydrogen peroxide.Do not place in direct sunlight.Keep away from heat sources." ifu 12383 rev 3.0 (comfort3d bite splint) contains the following statement for the cleaning procedures in the general safety and precautions section: "brush and floss your teeth before use.Rinse mouth well with clean water before inserting the nightguard.Rinse appliance well with clean, cool water before and after use.Clean comfort3d bite splint with clean, cool water only, and let it air dry." 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: 3D COMFORT 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: 15760825
• MDR Text Key: 303336009
• Report Number: 3011649314-2022-00602
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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: Male