MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. XTRA SILENT NITE GUARD; THERMOFORM MOUTHGUARD

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

It was reported that the patient had a reaction to the silent nite that was issued.It is unclear when the patient received the device, when the patient first used the device, or when the reaction occurred or resolved.

Manufacturer Narrative

The device has not been returned.If/when there is more information provided, a supplemental report will be submitted.Udi is not applicable with the exception of serial number as the device is manufactured by prescription.Implanted date is not applicable as the device is manufactured by prescription and not implantable.

Manufacturer Narrative

Capa 2023-006 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.Supplier (erkodent) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Lot# e-pro: 3mm11840204 (erkoloc-pro) was manufactured from march 21, 2022 and was assigned an expiration of march 2025.Lot#: 22145 (connectors) was manufactured from november 11, 2021 and was assigned an expiration november 2024.Lot#: 10m-oskv-22 (bite tabs) was manufactured from may 24, 2022 and was assigned an expiration of 1 year.Lot#: slcn l31eac2560 (hardware) was manufactured from september 1, 2022 and was assigned an expiration of august 31, 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 customer did not return the complaint part for investigation.However, the non-visual device investigation has been completed.Root cause a root cause for this complaint cannot be explicitly determined.Ifu 7322 rev 6.0 (silent nite sleep appliance instructions for use) provides warning in "precautions" section: · do not soak the device in mouthwash, denture cleanser, hot water (> 50 °c) or alcohol.· do not wash the device with soap, toothpaste, or mouthwash.· do not dry the device with a blow dryer.· do not store in direct sunlight." per the reported information, the patient has an allergy to latex.Supplier erkodent reviewed the incident details and stated "it is unusual that a real allergic reaction starts only after 8 days, it could have other causes." 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: XTRA SILENT NITE GUARD
• 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: 15760185
• MDR Text Key: 303336088
• Report Number: 3011649314-2022-00603
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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 Sex: Male