MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. 3D COMFORT SPLINT

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/03/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced redness and swelling on the tongue, from the tip to the lateral borders.The gums were also affected.It is unclear when the patient received the device.However, the patient first used the device (b)(6) 2021 with the reaction occuring that evening.The device was discontinued on (b)(6) 2022 but it is unclear when the symptoms resolved.

Manufacturer Narrative

The device has not been returned.If/when there is more information provided, 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.Implant date-explant date: is not applicable as the device is manufactured by prescription and not implantable.

Manufacturer Narrative

Capa (b)(4).The device has not been returned.However, the non-visual device evaluation has been completed and the results are as follows: dhr results lot number was not provided; therefore no dhr results could be determined.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 did not return the product for investigation.No picture provided by the customer to review.Root cause a root cause for this complaint cannot be explicitly determined.No stock product was available for review.Fmea review results ifu 012579 rev 1.0 (clearsplint instruction for use) states "brush and floss before using clearsplint.After use, rinse the bite splint with water and store dry.Clean bite splint with soap and warm water only." ifu 012579 provides warning "do not clean or soak in mouthwash; do not use denture cleanser; do not place do not place the clearsplint in hot or boiling water or expose to excessive heat (such as direct sunlight).This may distort the appliance; do not use alcohol or hydrogen peroxide." per rpt 012574 rev.3.0 (clearsplint biocompatibility report), 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: 3D COMFORT SPLINT
• Type of Device: 3D COMFORT SPLINT
• 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: 14467170
• MDR Text Key: 292518028
• Report Number: 3011649314-2022-00286
• 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: 12/15/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/22/2022
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Race: White