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

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 suffered a reaction to his gums, and lips, and felt as if the tip of his tongue had a burning sensation.When examined the doctor did not find that it was ulcerated.This occured in (b)(6) 2017, and it occured for about 3 to 4 weeks.The patient reported the reaction a few months later, not realizing that it was a reaction at first.It was reported that the patient possibly could have developed an allergy when wearing the guard.Patient does not notice this reaction when the device is not worn.The doctor did not prescribe any perscription for the symptoms as there was nothing visable inside the patient's mouth to treat.It was recommended that the patient no longer use the appliance and another mouth guard was make for the patient in the doctors office.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: section h3: the device was returned, however the date of returned is unknown.Device history record: no dhr was available for review since the device was fabricated per physician's prescription only.Stock product reviewed: no stock product was available for review since the device was fabricated per physician's prescription only.Returned sample: complaint investigator visually inspected the returned device.Both upper and lower trays were returned with original case.The results were summarized below.Roughness - the edge was smooth.Crack - no major cracks were found.Delamination - layers were intact and were not separated.Discoloration - color turns yellowish due to the normal usage.General cleanliness - patient did not maintain the cleanliness of the device.Case was returned in a good condition with label.Accessories - the connector and tabs were all intact.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.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 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 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 SLEEP DEVICE
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 7054746
• MDR Text Key: 92833692
• Report Number: 3011649314-2017-00088
• 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: 12/16/2020

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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR