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 Type  Injury  

Event Description

It was reported that the patient had a reaction to the comfort hard soft splint that was issued.The patient received the device on 12-20-2015.It is unclear when the patient first used the device, or when the reaction occurred or resolved.

Manufacturer Narrative

The device has not been returned.If/when there is more information provided, a supplemental report will be submitted.Date of event: this information was not provided when asked.Relevant tests/laboratory data/other relevant history: this information was not provided when asked.Serial #: 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: unable to retrieve lot number; therefore no dhr was reviewed.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 and no picture was provided.However, the non-visual device investigation has been completed.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu 012579 rev 1 (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 rev 1 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." 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.Per rpt 012574 rev.3 (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: 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: 14523509
• MDR Text Key: 292823024
• Report Number: 3011649314-2022-00338
• 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: 11/20/2023

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: 04/28/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2023
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: Asian