MAUDE Adverse Event Report: XTRA SILENT NITE; ANTI SNORING NIGHTGUARD

Lot Number 1107158359

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

Patient Problem Reaction (2414)

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.Lot # is not applicable with the exception of lot number as the device is manufactured by prescription.Implant and explant dates are not applicable as the device is manufactured by prescription and is not implantable.

Event Description

It was reported that the patient had a possible allergic reaction forming on papilla / gingival area.The reaction lasted over a period of a few days.The provider has instructed patient to stop wearing appliance.

Manufacturer Narrative

The device has not been returned.However, the non-visual device investigation has been completed and the results are as follows: dhr review: 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 lots and confirmed no manufacturing deviation or abnormality.Lot# e-pro 3.0-11298 (erkoloc-pro blue) was manufactured from 05/20/19 and was assigned with 3 years expiration hardware lot# slcn21936 was manufactured from 09/11/2019 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 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".However, the customer did not provide the information regarding how the patient handled and maintained the device.Supplier erkodent reviewed the incident details and stated there was possibly too much pressure on the papilla's.Additionally, the doctor reported they altered the appliance with a composite material while they made adjustments.Material composition for the composite used was unknown.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
• MDR Report Key: 10430897
• MDR Text Key: 204185744
• Report Number: 3011649314-2020-00614
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1107158359
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2020
• 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