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  

Event Description

It was reported that the patient experienced mouth sores.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 device was worn on (b)(6) 2022.There are no medical history or allergies noted.

Manufacturer Narrative

The device has not been returned.If/when there is more information provided, a supplemental report will be submitted.

Manufacturer Narrative

The device was returned, the investigation has been completed and the results are as follows: 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.Supplier (erkodent) reviewed the associated material lot and confirmed.No manufacturing deviation or abnormality.Additionally, erkodent reported no further complaints for this material lot.Lot# e-pro 4.0-11771201 (erkoloc-pro) was manufactured from november 17, 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: complaint investigator reviewed the returned device.An upper splint was returned in the original case.The results were summarized: roughness - the flange was smooth; internal/external surfaces were smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device did not appear discolored.General cleanliness - the returned device appeared to be clean, free of debris or foreign particles.The returned device was visually inspected and no defect or abnormality was observed.There was no evidence found to indicate that the reported issue was caused by the device itself.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu 9091 rev 4.0 (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.However, the customer did not provide the information regarding how the patient handled and maintained the device.Supplier erkodent reviewed the incident details and determined an allergic reaction could not be ruled out.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device (haley) following iso 10993 (biological evaluation of medical devices) and the device was evaluated for potential cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The haley test article was thermoformed with layers of erkodent material (erkoloc-pro and erkodur).The test results were listed below and summarized in biocompatibility report for haley sleep device (rpt 9733 rev 1.0).For cytotoxicity testing, the test article extract showed no evidence of causing cell lysis or toxicity.This complaint will be kept on record for track 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: 14566496
• MDR Text Key: 293357815
• Report Number: 3011649314-2022-00315
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White