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 Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.The patients weight is not provided as it is not taken at the time of the appointment.Serial #: is not applicable with the exception of serial number as the device is manufactured by prescription.Implant date, explant date: the device is manufactured by prescription and not implantable.

Event Description

It was reported that the comfort hard splint caused an allergic reaction.The patient received and used on (b)(6) 2021, with the reaction occurring on the morning of (b)(6) 2021.The patient reported that she broke out in hives and was unable to breathe.The hives broke out on her face, arms, back and legs.The patients' eyes were also red and puffy.The patient was given benadryl and rinsed her mouth.The patient reached out to the provider and was told to add zyrtec along with the benadryl.The patient has no known allergies and there are no pre-existing conditions noted.At the time of delivery there was no allergy test completed.However, the patient is scheduled to be seen by an allergist.With regard to the device: the provider rinsed it with water prior to delivery.However, it is unknown how the patient cared for the device.The device has been returned.

Manufacturer Narrative

The device 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 (b)(4) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Lot# e-pro4.0-11659 (erkoloc-pro) was manufactured from 07/08/21 with an expiration of june, 2024.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Complaint investigator reviewed the returned device.An upper tray was returned with am original case.The returned device was visually inspected and no defect and abnormality was observed.There was no evidence found to indicate that the reported issue was caused by the device itself.The results were summarized below: roughness - the flange was smooth.Occlusal surface at incisors had visible adjustments (bur marks).Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device turned yellowish due to the usage.General cleanliness - the returned device appeared to be clean, free of debris or foreign particles.Root cause: the root cause for this complaint cannot be explicitly determined.Ifu 9091 rev 3.0 (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".It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.However, the customer did not provide any information regarding how the patient handled and maintained the device.Supplier (b)(4) reviewed the incident details and determined complaint description suggests an allergic reaction, but it remains unclear whether this is caused by the pure material or unknown foreign substances.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 test article was thermoformed with layers of (b)(4) 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; suite 25; irvine, CA 92612 ; 9495021907
• MDR Report Key: 12321625
• MDR Text Key: 266621661
• Report Number: 3011649314-2021-00297
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• 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: 18 YR
• Patient Sex: Female
• Patient Race: White