MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. COMFORT HARD SOFT SPLINT; THERMOFORM MOUTHGAURD

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/08/2022

Event Type  Injury  

Event Description

It was reported that the patient had a reaction to the comfort hard soft splint.It is unclear when the patient received the device.However, the device was first used (b)(6) 2022 with the reaction occurring that same day to the gingival tissue.The reaction resolved within 48 hours after the patient discontinued its use on (b)(6) 2022.

Manufacturer Narrative

The device has not been returned.If/when there is more information provided, a supplemental report will be submitted.

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 the dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Supplier (erkodent) reviewed the associated material lot and confirmed no material defects or changes could be detected.No manufacturing deviations or abnormalities are know.E-pro 4.0 - 11761112 (erkoloc-pro) was manufactured from (b)(6), 2021 and was assigned an expiration of (b)(6) 2024.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results no device has been returned from the customer and no picture was provided by the customer to review.However, the non-visual device investigation has been completed.A root cause for this complaint cannot be explicitly determined.No device has been returned for review.Ifu 9091 rev 5.0 (comfort h/s 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.This complaint will be kept on record for tracking and trending purposes.

• Brand Name: COMFORT HARD SOFT SPLINT
• Type of Device: THERMOFORM MOUTHGAURD
• 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: 14566156
• MDR Text Key: 293092005
• Report Number: 3011649314-2022-00311
• 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: 06/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Race: White