MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. XTRA SILENT NITE; ANTI SNORING NIGHTGUARD

Lot Number 1104423606

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 09/03/2019

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.The patient's race and ethnicity were not provided.This section is not applicable (with the exception of the lot number, d5,d8 and d10) as the device is manufactured per prescription only.

Event Description

It was reported that the patient had a reaction to the xtra silent night device.The patient received the device on (b)(6) 2019 and the reaction occurred on (b)(6) 2019 in the mandibular area.It was reported that there was swelling and redness in the lip area and in the - in canine and premolar area.With regards to the care of the device, the patient was instructed to clean the device water.The patient did not require any treatment.It is unclear how long the reaction remained after the patient discontinued the use of the device.The patient weight was not provided, as it is not taken at the time of the appointment.The patient has a history of hypertension.The patient medication amitriptyline and protonix.There are no reported allergies.The patient is convinced that he is allergic to polymer.The provider want to do a remake, but the patient is not willing to do it.

Manufacturer Narrative

The device has not been returned.However, the non-visual device investigation has been completed and the results are as follows: dhr results no dhr was available for review since the device was fabricated per physician's prescription only.Supplier (erkodent) reviewed the associated material lot and confirmed no material defects.Lot# ep3mm11272 (erkoloc-pro) was manufactured from 1/18/19 and was assigned with 3 years expiration.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results the device was not returned for investigation.Root cause a root cause for this complaint cannot be explicitly determined.Ifu 7322 rev 2.0 (silent nite sleep appliance instructions for use) provides warning in precautions "do not soak the device in mouthwash; denture cleanser, hot water 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 obtained information, patient was instructed to use water to clean the device.It was reported patient was allergic to polymer but not specified.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 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: XTRA SILENT NITE
• Type of Device: ANTI SNORING NIGHTGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont dr; suite p; irvine, ca
• MDR Report Key: 10144646
• MDR Text Key: 194945725
• Report Number: 3011649314-2020-00534
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K972424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1104423606
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR