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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/11/2022

Event Type  Injury  

Event Description

It was reported that the patient had a reaction to comfort hard soft splint.The device was delivered (b)(6) 2022 and used the same evening.The reaction occurred within the week.The patient experienced redness, swelling and sores on the lips where the guard touched.The device was discontinued within the week and it resolved "quickly." there is an allergy of keflex noted.The patient was advised to see an allergist but declined.

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.This information was not provided when asked.Serial number is not applicable with the exception of serial number as the device is manufactured by prescription.Implant date is not applicable as the device is manufactured by prescription and not implantable.

Manufacturer Narrative

Capa 2023-006.The device has not been returned.However, the non-visual device evaluation has been completed and the results are as follows: dhr results: no lot number provided, dhr not completed.Stock product reviewed results: no lot number provided.Therefore, no stock product review was completed.Investigation methods/results: the customer has not returned, the complaint part 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 provider is not sure how the patient handled and cared for the device.Ifu-12383, rev 3.0, (comfort3d 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-12383, rev 3.0, 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".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).Correction: b3: date of event.

• 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: 15330178
• MDR Text Key: 299042486
• Report Number: 3011649314-2022-00482
• 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: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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: 59 YR
• Patient Sex: Female
• Patient Race: White