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  

Manufacturer Narrative

The device has not been returned.If/when there is more information provided, a supplemental report will be submitted.Complete device information not provided when asked.This is the third of three implant complaints for the same patient, see manufacturer report for the remaining complaint: 3011649314-2021-00496, 3011649314-2022-00113.

Event Description

It was reported that the patient had a reaction to the comfort hard soft splint.The patient received the device (b)(6) 2021 and used it the same evening.The same reaction occurred (date unknown).The patient experienced irritation of the gums and lips, both upper and lower.The patient discontinued the device (date unknown) it is unclear when the reaction resolved.However, there was slight erythema noted.The patient used benadryl otc as a treatment.The patient has an allergy to penicillin, sulfa, codeine, pollen allergies, cleaning chemical, some make up creams.There is a sensitivity to latex.With regards to the device: the device was cleaned with mild soap and cool water.The patient used water only.The device is scheduled to be returned.

Manufacturer Narrative

The device has not been returned.However, the non-visual device evaluation has been completed and the results are as follows: dhr results lot information not provided - dhr could not be reviewed.Additionally, supplier (erkodent) could not review the associated material lot.Section d2: updated to reflect the new information provided.Stock product reviewed results: lot information not provided - stock product could not be reviewed.Investigation methods/results: attempts to retrieve the device or determine the status of the device have been made but to no avail.However, the non-visual device investigation has been completed.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".Per the reported information, the patient experienced irritation of the gums and lips, both upper and lower.It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.The provider reported the device was cleaned with mild soap and cool water.Additionally, the provider noted the patient has an allergy to penicillin, sulfa, codeine, pollen allergies, cleaning chemical, some make up creams.There is a sensitivity to latex.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 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 sleep device (rpt 9733 rev 1.0) · for cytotoxicity testing, the test article extract showed no evidence of causing cell lysis or toxicity.· for skin irritation, there was no erythema and no edema observed on the skin of the animals treated with the test article.· for sensitization testing, the test article extracts showed no evidence of causing delayed dermal contact sensitization.· the test article showed nonirritant to the oral mucosa as compared to the control article.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: 13999744
• MDR Text Key: 289767534
• Report Number: 3011649314-2022-00114
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White