MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. SILENT NIGHT

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

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for an evaluation, however the incident is under investigation.Once completed, a supplemental report will be filed.

Event Description

It was reported that a patient reported a reaction that occurred around the gingival area of the entire arch.It was reported that the patient felt sore and had small bumps in the area that the night guard laid.The patient experienced this reaction since the time she received the night guard and wore it.This reaction started back in (b)(6), however exact date is unknown.Nothing was prescribe to treat the patient, the patient was instructed to stop the usage of the night guard and to use a different one.The patient did not report the incident until her 6 month check-up.There is no device to be returned.

Manufacturer Narrative

The device was not available to the investigator.However a non-visual investigation has been completed and the results are as follows: dhr results no dhr was available for review.The device was fabricated per physician's prescription only.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 available for investigation.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 was instructed to handle and maintain the device.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 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: SILENT NIGHT
• Type of Device: SILENT NIGHT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 7054921
• MDR Text Key: 92833711
• Report Number: 3011649314-2017-00089
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 59