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

Device Problem Insufficient Information (3190)

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.Serial number: is not applicable with the exception of serial number as the device is manufactured by prescription.Date implanted: is not applicable as the device is manufactured by prescription and not implantable.

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.It is unclear when the patient received the device, when the patient first used the device, or when the reaction occurred.

Event Description

The following new information was provided: the device was provided on (b)(6) 2022 with the reaction occurring immediately after insertion.The patient experienced "tingling and redness on roof of mouth and tip of tongue.As well as blisters on lips and a burning sensation." the patient was prescribed dexamethasone steroid rinse twice a day for a week.The device was discontinued (b)(6) 2022 with the reaction lasting for approximately two weeks.The patient was seen by an ear nose and throat provider and a biopsy was taken (those results are not available).There is an allergy to sulfa noted.The current status is noted as lingering redness and mild burning.With regards to the device: the device was cleaned with cavacide then rinsed with water and dried.The patient rinsed the device with warm water and brushed with toothbrush and let it air dry.

Manufacturer Narrative

Additional information provided by the provider: section a2: updated to reflect the new information provided.Section a3: updated to reflect the new information provided.Section a4: updated to reflect the new information provided.Section b2: updated to reflect the new information provided.Section b3: updated to reflect the new information provided.Section b5: updated to reflect the new information provided.Section b7: updated to reflect the new information provided.The patients ethnicity is noted as "indian".

Manufacturer Narrative

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.Certificate of analysis provided.Supplier (erkodent) reviewed the associated material lot and confirmed no material defects or changes could be detected.No manufacturing deviations or abnormalities are known.E-pro 4.0 - 11770112 (erkoloc-pro) was manufactured from november 02, 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: 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: root cause: a root cause for this complaint cannot be explicitly determined.No stock product was available 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 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: 14569140
• MDR Text Key: 293355470
• Report Number: 3011649314-2022-00318
• 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: Consumer,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2023

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: 05/06/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 06/13/2022; 05/02/2023
• Supplement Dates FDA Received: 06/16/2022; 06/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 64 KG