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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

The device has been returned.Once the investigation is complete a supplemental report will be submitted.Is not applicable with the exception of serial number as the device is manufactured by prescription.Is not applicable as the device is manufactured by prescription and not implantable.

Event Description

The device was delivered (b)(6) 2022 and used the same evening.The reaction date is unknown.The patient experienced swelling of the lips.It is unknown when the device was discontinued, but the reaction resolved within 2 days.There was no medical treatment rendered nor are there any allergies noted.There is no information provided on the care of the device by either the provider or the patient.The device was returned.

Manufacturer Narrative

(b)(4).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, therefore no dhr review was 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 customer did not provide the information regarding how the patient handled and maintained the device.Ifu 9091 rev 5.0 (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 (for cleaning).Do not use alcohol or hydrogen peroxide.Do not place in direct sunlight.Keep away from heat sources." ifu 9091 rev 5.0 (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." correction - b5 describe event or problem, d9 device available for evaluation, h3 device evaluated by manufacturer - the device was inadvertently marked as returned but upon further review, the product has not been received.

• 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: 16090582
• MDR Text Key: 306593638
• Report Number: 3011649314-2022-00748
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• 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
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2022
• 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: 31 YR
• Patient Sex: Male
• Patient Race: White