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.Model # 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.

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, when the patient first used the device, or when the reaction occurred.However, it is noted that the patient had inflamed gums while wearing the guard.

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 results, no lot number was received.Stock product reviewed results unable to retrieve results, no lot number was reviewed.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 device has been returned for review.

• 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: 15158914
• MDR Text Key: 297211308
• Report Number: 3011649314-2022-00433
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• 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: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• 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 Sex: Female