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

Lot Number 1116198144

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If / when the device is returned an investigation will be carried out and a supplemental report will be submitted.This complaint will be kept on record for track and trending purposes.Section a: a2: age at time of event, date of birth was asked but not provided.A3: patient's sex was asked but not provided.A4: patient's weight was asked but not provided.A6: patient's race was asked but not provided.

Event Description

Received an email on (b)(6) 2023 from the thermoform group regarding a new complaint.It was reported that the patient had a possible allergic reaction to the comfort hard soft splint that was issued.It is unclear when the patient received the device or when the patient first used the device.However, it is noted that the patient experienced a raw circle on the tongue and maxilla gingiva.It is unclear how long the patient wore the device, but it is noted that the symptoms resolved once the patient stopped using the device.Patient claims to have no known allergies.About the device: the patient was encouraged to stop using the appliance and return for further research.

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 manufacturing deviation or abnormality.E-pro: lot# 11770112 was manufactured from november 2, 2021 and was assigned an expiration of november 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 customer did not return the reported device for investigation to date.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 9091 rev 4.0 (comfort h/s bite splint) contains the following statement in the warning section: "use only clear, cool water to wash the device.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 9091 rev 4.0 (comfort h/s 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 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.".

• Brand Name: COMFORT HARD-SOFT SPLINT
• Type of Device: THERMOFORM MOUTHGUARD, PRODUCT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine 92612
• Manufacturer Contact: herbert crane ; 2144 michelson drive; irvine, CA 92612 ; 9495021907
• MDR Report Key: 17599218
• MDR Text Key: 321690973
• Report Number: 3011649314-2023-00572
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1116198144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1