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 will not been returned per the provider.Once a non-visual investigation is complete a supplemental mw will be submitted.This information was not provided when asked.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.This is the second of two complaints.See mfr 3011649314-2022-000528.

Event Description

The patient was issued the device on (b)(6) 2017 and first used the same evening.The patient reveals that the reaction occurred 6 months ago (exact date unknown).The reaction was noted as swelling in her lips.The device was discontinued, and the swelling went away.The patient used the device again 4-5 days and the reaction re-occurred.There was no medical treatment required.The patient has an allergy to bee stings and saw an allergist, but not as it relates to the reaction to the device.With regard to the device: the device was cleaned with water and a brush and the patient was instructed to do the same.The device is not available for return.

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: the dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.This investigation represents a second attempt and reaction to the patient.Supplier (erkodent) reviewed the associated material lot previously with first attempt in investigation #(b)(4) ((b)(4)) and confirmed no manufacturing deviation or abnormality.Lot# e-pro 4.0-11167 (erkoloc-pro) was manufactured from march 3, 2017 and was assigned an expiration of march 2022.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 stated the device is not available for return.However, the non-visual device investigation has been completed.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu 9091 rev 2.0 (comfort h/s bite splint instruction for use) states to use only clear, cool water to wash the device.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".Supplier erkodent reviewed the incident details and determined the complaint is more likely a mechanical irritation.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.· 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: 13588317
• MDR Text Key: 286049468
• Report Number: 3011649314-2022-00054
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• 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: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2017
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White